<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03784794</url>
  </required_header>
  <id_info>
    <org_study_id>099/21012018/MEDCRITICAHENM</org_study_id>
    <nct_id>NCT03784794</nct_id>
  </id_info>
  <brief_title>Patient Blood Management for Massive Obstetric Hemorrhage</brief_title>
  <official_title>ROTEM Guided and Hemostatic Drugs Algorithms vs Standard Coagulation Test and Hemocomponent for Massive Obstetric Hemorrhage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Angel Augusto Perez Calatayud</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Grupo Mexicano para el Estudio de la Medicina Intensiva</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Grupo Mexicano para el Estudio de la Medicina Intensiva</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obstetric Hemorrhage continues to be the first cause of maternal morbidity and mortality&#xD;
      around the world especially in middle to low income countriesThe blood components are high&#xD;
      value resources; however, its use has been shown to be a risk factor of known complications.&#xD;
      The aim of the study is to compare two algorithms of coagulation management in massive&#xD;
      obstetric hemorrhage Methods A randomized prospective trial single center two arms study in&#xD;
      patients with severe obstetric hemorrhage (PPH &gt; 1000) 2 different transfusion protocols one&#xD;
      guided by thromboelastometry and hemostatic drugs (protrombine complex concentrate and&#xD;
      fibrinogen concentrate) and the second guided by standard coagulation test and&#xD;
      hemocomponents. Sample is calculated to known variance, Analyses are intention-to-treat&#xD;
      without imputation, with outcomes will be performed between groups using mixed-effects two&#xD;
      level regression models. For binary outcomes, a logistic model will be used and results&#xD;
      presented as adjusted odds ratios (ORs) alongside 95% confidence intervals (CIs). Count data&#xD;
      will be analysed using Poisson multilevel or negative binomial models.&#xD;
&#xD;
      Primary Outcome Parameter:&#xD;
&#xD;
      Compare between the two protocols:&#xD;
&#xD;
      Number of allogeneic blood products transfused intra-op, within 24h after screening and&#xD;
      in-hospital (RBC, Platelets and FFP; separate and overall)&#xD;
&#xD;
      Secondary Outcome Parameter:&#xD;
&#xD;
      Analysis of mortality, lenth of stay admission to the ICU, hysterectomy surgical&#xD;
      reintervencion, Transfuse associated circulatory overload, Transfusion associated Acute lung&#xD;
      injury, health associated infection will be measured as secondary outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction Obstetric Hemorrhage continues to be the first cause of maternal morbidity and&#xD;
      mortality around the world especially in middle to low income countries. Copying trauma&#xD;
      transfusion therapies now a days algorithms have been developing for 2.1.1 transfusion in&#xD;
      massive obstetric hemorrhage. Blood products, play an essential role in the management of&#xD;
      these patients, either during resuscitation or definitive treatment. Early transfusion,&#xD;
      defined as that required in the first 24 hours after admission, it is required in about 5%&#xD;
      that enters the hospital and about 3% comes to require massive transfusion. The blood&#xD;
      components are high value resources; however, its use has been shown to be a risk factor for&#xD;
      infectious transfusion related immunomodulation, and noninfectious complications (TRALI,&#xD;
      TACO), development of systemic inflammatory response, multiple organ failure and death. A&#xD;
      liberal transfusion policy can further introduce the risk of a patient who is already&#xD;
      committed.&#xD;
&#xD;
      Patient blood management is an evidence-based, multidisciplinary approach to optimizing the&#xD;
      care of patients who might need transfusion. PBM encompasses all aspects of patient&#xD;
      evaluation and clinical management surrounding the transfusion decision-making process,&#xD;
      including the application of appropriate indications, as well as minimization of blood loss&#xD;
      and optimization of patient red cell mass.&#xD;
&#xD;
      The aim of the study is to compare two algorithms of coagulation management in massive&#xD;
      obstetric hemorrhage Methods A randomized prospective trial single center two arms study in&#xD;
      patients with severe obstetric hemorrhage (PPH &gt; 1000) 2 different transfusion protocols one&#xD;
      guided by thromboelastometry and hemostatic drugs (protrombine complex concentrate and&#xD;
      fibrinogen concentrate) and the second guided by standard coagulation test and&#xD;
      hemocomponents.&#xD;
&#xD;
      Randomization for the patients will be made for every obstetric patient that enters the&#xD;
      obstetric ward for attention of partum, and will be asked to sign consent, and the patients&#xD;
      will be selected for each group of the study. Only does that have severe PPH will be entering&#xD;
      the protocol with the algorithm for management previously selected. Demographic&#xD;
      caracteristics will include Ethnicity, Body weight (KG), body height (CM) and BMI at hospital&#xD;
      admission, Previous deliveries, Previous Caesarean section, Pre-eclampsia during pregnancy,&#xD;
      History of obstetric hemorrhage, History of other kind of hemorrhage, Onset of labor&#xD;
      (spontaneous, induced, no labor) Multiple gestation (singleton, twins, triplet) Reported&#xD;
      cause of obstetric hemorrhage (placenta previa, placenta accreta, placenta abruption,&#xD;
      retained placenta, uterine atony, trauma, surgical bleeding Mode of delivery (spontaneous&#xD;
      vaginal, instrumental vaginal , elective Caesarean section, non-elective Caesarean section)&#xD;
      Baseline Hb, Hct, Plt count, Fibrinogen (Clauss), PT/INR, PTT (at hospital admission)&#xD;
      Estimated blood loss at study entry (ML).&#xD;
&#xD;
      Treatment algorithms are evidence based and the management of coagulopathy is based on treat&#xD;
      first what kills fist (ATLS proposal)&#xD;
&#xD;
      Group A:&#xD;
&#xD;
      THROMBOELASTOMETRY-GUIDED ALGORITHM FIBRINOGEN CONCENTRATE FIBTEM A5 &lt; 12 MM AND EXTEM A5 &lt;&#xD;
      40 MM FIBTEM A5 = 9-11 MM → 2 G FIBRINOGEN CONC. (25 MG/KG); FIBTEM A5 = 4-8 MM → 4 G&#xD;
      FIBRINOGEN CONC. (50 MG/KG); FIBTEM A5 &lt; 4 MM → 6 G FIBRINOGEN CONC. (75 MG/KG) GOAL: FIBTEM&#xD;
      A5: 12-16 MM PLATELETS EXTEM A5 &lt; 40 MM AND FIBTEM A5 ≥ 12 MM EXTEM A5 &lt; 40 MM → 1 PLATELET&#xD;
      POOL OR APHERESIS; EXTEM A5 &lt; 30 MM → 2 PLATELET POOL OR APHERESIS GOAL: EXTEM A5: 40-50 MM&#xD;
      PROTROMBIN COMPLEX CONCENTRATE EXTEM CT &gt; 80 SEC AND FIBTEM A5 ≥ 8 MM 4F-PCC 20 IU/KG (F II,&#xD;
      VII, IX and X) GOAL: EXTEM CT ≤ 80 SEC NO INTERVENTION FIBTEM A5 ≥ 12 MM AND EXTEM A5 ≥ 40 MM&#xD;
      AND EXTEM CT &gt; 80 SEC NO FIBRINOGEN, CRYO, PLATELETS, 4-PCC, FFP; TRANSFUSE RBC IF Hb &lt; 7&#xD;
      G/DL GOAL: Hb &gt; 7.5 G/DL&#xD;
&#xD;
      Group B RATIO / STANDRAD LAB TEST-GUIDED ALGORITHM CRYOPRECIPITATE FIBRINOGEN (CLAUSS) &lt; 250&#xD;
      MG/DL FIB 200-250 MG/DL → CRYOS, PACK OF 10 (25 MG/KG); FIB 100-200 MG/DL → CRYOS, PACK OF 20&#xD;
      (50 MG/KG); FIB &lt; 100 MG/DL → CRYOS, PACK OF 30 (75 MG/KG) GOAL: FIB &gt; 250 MG/DL PLATELETS&#xD;
      PLATELET COUNT &lt; 100/µL PLT &lt; 100/µL → 1 PLATELET POOL OR APHERESIS; PLT &gt; 50/µL → 2 PLATELET&#xD;
      POOL OR APHERESIS GOAL: PLT COUNT &gt; 100/µL FRESH FROZEN PLASMA TP AND/OR TTP PATHOLOGICAL&#xD;
      INR, 2.0-4.0 → FFP 20 ML/KG GOAL: TP AND TTP NORMAL AND INR &lt; 2.0 NO LAB RESULTS AVAILABLE&#xD;
      TRANSFUSE RED BLOOD CELLS IF Hb &lt; 7 G/DL; GIVE 1 UNIT FFP EVERY 2 UNITS OF RBC TRANSFUSED&#xD;
      GOAL: Hb &gt; 7.5 G/DL Statistical analysis Sample is calculated to known variance. The&#xD;
      investigators calculated that 100 women will be needed to provide 80% power at the two-sided&#xD;
      5% level to detect a difference of total allogeneic units between groups. With a total of 100&#xD;
      patients 50 in each arm, with a first revision of results after recruiting 50 patients (25 in&#xD;
      each arm). Analyses are intention-to-treat without imputation, with outcomes will be&#xD;
      performed between groups using mixed-effects two level regression models. For binary&#xD;
      outcomes, a logistic model will be used and results presented as adjusted odds ratios (ORs)&#xD;
      alongside 95% confidence intervals (CIs). For continuous outcomes, a linear regression model&#xD;
      will be performed and results presented as difference in adjusted means (arm A vs arm B)&#xD;
      alongside 95% CIs. Count data will be analysed using Poisson multilevel or negative binomial&#xD;
      models if over-dispersion is evident and presented as incident rate ratios (IRRs).&#xD;
&#xD;
      Objectives&#xD;
&#xD;
      Primary Outcome Parameter:&#xD;
&#xD;
      Compare between the two protocols:&#xD;
&#xD;
      Number of allogeneic blood products transfused intra-op, within 24h after screening and&#xD;
      in-hospital (RBC, Platelets and FFP; separate and overall)&#xD;
&#xD;
      Secondary Outcome Parameter:&#xD;
&#xD;
      Compare between the two arms Number of packs of Cryo (pack of 5 ~ 1 G Fibrinogen), Fibrinogen&#xD;
      Concentrate (G), and PCC (500 UI) administered intra-op, within 24h after screening and&#xD;
      in-hospital Incidence ≥ 5 U RBC transfused (first 24h after screening) Incidence ≥ 10 U RBC&#xD;
      transfused (first 24h after screening) Incidence of RBC, Platelets, FFP, Cryo, Fibrinogen&#xD;
      Concentrate, and PCC transfusion/administration (intra-op, first 24h and in-hospital) Total&#xD;
      volume of blood products and coagulation factor concentrates transfused/administered&#xD;
      (intra-op, first 24h and in-hospital) Infusion: Crystalloid (ML) and Colloids (Type; ML)&#xD;
      intra-op and within 24h after screening Overall estimated blood loss (EBL, ML) Time to&#xD;
      bleeding control (time from study entry to last hemostatic intervention/transfusion)&#xD;
      Incidence of coagulopathy (detected by thromboelastometry or standard coagulation laboratory&#xD;
      tests) Incidence of hysterectomy Incidence of re-surgery Incidence of TACO Incidence of TRALI&#xD;
      Incidence of surgical site infection or sepsis Incidence of ICU admission Length of stay&#xD;
      (LOS) at ICU and hospital In-hospital mortality First post-op Hb, Hct, Plt count, Fibrinogen&#xD;
      (Clauss), PT, INR, PTT (recovery room or ICU) Last Hb, Hct, Plt count, Fibrinogen (Clauss),&#xD;
      PT, INR, PTT before discharge from hospital Total acquisition costs of allogeneic blood&#xD;
      products and coagulation factor concentrates HYPOTHESIS. The algorithm guided by ROTEM plus&#xD;
      the use of hemostatic drugs, are more efficient for the reversion of coagulopathy due to&#xD;
      obstetric hemorrhage, than the standard treatment group, decrases the risk of development&#xD;
      known complications, decreases the need of blood transfusions, decreases morbidity and&#xD;
      mortality associated to PPH, length of stay, admissions to the intensive care unit and days&#xD;
      of mechanical ventilation. Without a significant increase in costs.&#xD;
&#xD;
      RELEVANCE AND EXPECTATIONS To offer a safe alternative in the treatment of severe obstetric&#xD;
      hemorrhage, which reduces the risk of transfusion associated complications,&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Group A Fibrinogen Concentrate, Protrombin Complex Concentrate, trhromboelastometry guided Group B Cryoprecipitates, fresh frozen plasma, standard coagulation lab test</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Blood products transfused</measure>
    <time_frame>24 hrs</time_frame>
    <description>Number of allogeneic blood products transfused intra-op, within 24h after screening and in-hospital (RBC, Platelets and FFP; separate and overall)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of hemocomponents or fibrinogen concentrates needed to treat hypofibrinogenemia</measure>
    <time_frame>day 0 to day 15</time_frame>
    <description>Number of packs of Cryo (pack of 5 ~ 1 G Fibrinogen), Fibrinogen Concentrate (G), and PCC (500 UI) administered intra-operating</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Red Blood Cells transfusion (RBC)</measure>
    <time_frame>day 0 to day 15</time_frame>
    <description>Incidence ≥ 5 U RBC transfused</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Massive Red Blood Cells transfusion (RBC)</measure>
    <time_frame>day 0 to day 15</time_frame>
    <description>Incidence ≥ 10 U RBC transfused (first 24h after screening)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>estimated blood loss</measure>
    <time_frame>day 0 to day 15</time_frame>
    <description>Overall estimated blood loss (EBL, ML)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to bleeding control</measure>
    <time_frame>24 hrs</time_frame>
    <description>time from study entry to last hemostatic intervention/transfusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of coagulopathy</measure>
    <time_frame>day 0 to day 15</time_frame>
    <description>detected by thromboelastometry or standard coagulation laboratory tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of hysterectomy</measure>
    <time_frame>day 0 to day 15</time_frame>
    <description>number of obstetric hysterectomy for bleeding control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of re-surgery</measure>
    <time_frame>day 0 to day 15</time_frame>
    <description>number of procedures necessary for bleeding control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Transfused associated circulatory overload</measure>
    <time_frame>day 0 to day 15</time_frame>
    <description>number of patients with transfused associated circulatory overload</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of surgical site infection or sepsis</measure>
    <time_frame>day 0 to day 15</time_frame>
    <description>number of patients that developed health care related infections or sepsis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of ICU admission</measure>
    <time_frame>day 0 to day 15</time_frame>
    <description>number of patients that require admission to the ICU for complications related to hipovolemic shock</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital mortality</measure>
    <time_frame>day 0 to day 15</time_frame>
    <description>number of deaths</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Post Partum Hemorrhage</condition>
  <condition>Fibrinogenolysis; Hemorrhage</condition>
  <condition>Fibrinogen; Deficiency, Acquired</condition>
  <condition>Massive Hemorrhage</condition>
  <condition>Transfusion Related Complication</condition>
  <arm_group>
    <arm_group_label>Thromboelastometry</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Decision to treat will be guided with thromboelastometry results, for fribrinogen deficiency the investigators will treat with fibrinogen concentrate (human), for correction of factor deficiency Prothrombin Complex Concentrates, Platelets with the use of platelets and Red Blood Cells for correcting hemoglobin levels</description>
  </arm_group>
  <arm_group>
    <arm_group_label>STANDARD COAGULATION TEST ALGORITHM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Decision to treat will be guided by standard cogulation lab test (Thrombine time, Active Thromboplastine time, Clauss fibrinogen, platelets count etc) for fribrinogen deficiency the investigators will treat with cryoprecipitates, for correction of factor deficiency fresh frozen plasma, Platelets with the use of platelets and Red Blood Cells for correcting hemoglobin levels</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Thromboelastometry</intervention_name>
    <description>devices generate output by transducing changes in the viscoelastic strength of a small sample of clotting blood (300 µl) to which a constant rotational force is applied. These point of care devices allow visual assessment of blood coagulation from clot formation, through propagation, and stabilization, until clot dissolution. Computer analysis of the output allows sophisticated clot formation/dissolution kinetics and clot strength data to be generated</description>
    <arm_group_label>Thromboelastometry</arm_group_label>
    <other_name>ROTEM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Standard Coagulation Test</intervention_name>
    <description>coagulation tests, such as the prothrombin time (PT), activated partial thromboplastin time (aPTT), and thrombin time (TT), to assess blood clotting function in patients. Clauss Fibrinogen.</description>
    <arm_group_label>STANDARD COAGULATION TEST ALGORITHM</arm_group_label>
    <other_name>blood coagulation test</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fibrinogen Concentrate Human</intervention_name>
    <description>To treat acquired fribinogen deficiency investigators will treat with the following doses FIBTEM A5 = 9-11 MM a 2 G FIBRINOGEN CONC. (25 MG/KG); FIBTEM A5 = 4-8 MM a 4 G FIBRINOGEN CONC. (50 MG/KG); FIBTEM A5 &lt; 4 MM a 6 G FIBRINOGEN CONC. (75 MG/KG)</description>
    <arm_group_label>Thromboelastometry</arm_group_label>
    <other_name>Chlotafact</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prothrombin Complex Concentrates</intervention_name>
    <description>to treat acquired factor deficiency investigators will treat as follows PROTROMBIN COMPLEX CONCENTRATE EXTEM CT &gt; 80 SEC AND FIBTEM A5 ≥ 8 MM 4F-PCC 20 IU/KG (F II, VII, IX and X) GOAL: EXTEM CT ≤ 80 SEC</description>
    <arm_group_label>Thromboelastometry</arm_group_label>
    <other_name>Confidex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Platelets</intervention_name>
    <description>PLATELETS EXTEM A5 &lt; 40 MM AND FIBTEM A5 ≥ 12 MM EXTEM A5 &lt; 40 MM → 1 PLATELET POOL OR APHERESIS; EXTEM A5 &lt; 30 MM → 2 PLATELET POOL OR APHERESIS GOAL: EXTEM A5: 40-50 MM or PLATELET COUNT &lt; 100/µL PLT &lt; 100/µL → 1 PLATELET POOL OR APHERESIS; PLT &gt; 50/µL → 2 PLATELET POOL OR APHERESIS GOAL: PLT COUNT &gt; 100/µL</description>
    <arm_group_label>STANDARD COAGULATION TEST ALGORITHM</arm_group_label>
    <arm_group_label>Thromboelastometry</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Red Blood Cells</intervention_name>
    <description>Transfuce Red Blood Cells if Hemoglobine levels &lt; 7 G/DL;&#xD;
1 unit of FFP for every unit of RBC Transfused GOAL: Hb &gt; 7.5 G/DL</description>
    <arm_group_label>STANDARD COAGULATION TEST ALGORITHM</arm_group_label>
    <arm_group_label>Thromboelastometry</arm_group_label>
    <other_name>RBC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fresh Frozen Plasma</intervention_name>
    <description>FRESH FROZEN PLASMA TP AND/OR TTP PATHOLOGICAL INR, 2.0-4.0 → FFP 20 ML/KG GOAL: TP AND TTP NORMAL AND INR &lt; 2.0</description>
    <arm_group_label>STANDARD COAGULATION TEST ALGORITHM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cryoprecipitates</intervention_name>
    <description>FIBRINOGEN (CLAUSS) &lt; 250 MG/DL FIB 200-250 MG/DL → CRYOS, PACK OF 10 (25 MG/KG); FIB 100-200 MG/DL → CRYOS, PACK OF 20 (50 MG/KG); FIB &lt; 100 MG/DL → CRYOS, PACK OF 30 (75 MG/KG) GOAL: FIB &gt; 250 MG/DL</description>
    <arm_group_label>STANDARD COAGULATION TEST ALGORITHM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with severe obstetric hemorrhage of any cause&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        obstetric hemorrhage patients derived from other hospitals Patients with less than 1000 ml&#xD;
        of estimated blood loss those who do not want to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>all female patients with severe obstetric hemorrhage (more than 1000 ml of estimated blood loss)</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angel Augusto Perez Calatayud, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head Obstetric ICU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Especialidades Del Niño Y La Mujer</name>
      <address>
        <city>Querétaro City</city>
        <state>Queretaro</state>
        <zip>76090</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Mallaiah S, Barclay P, Harrod I, Chevannes C, Bhalla A. Introduction of an algorithm for ROTEM-guided fibrinogen concentrate administration in major obstetric haemorrhage. Anaesthesia. 2015 Feb;70(2):166-75. doi: 10.1111/anae.12859. Epub 2014 Oct 7. Erratum In: Anaesthesia. 2015 Nov;70(11):1334.</citation>
    <PMID>25289791</PMID>
  </reference>
  <reference>
    <citation>Mallaiah S, Chevannes C, McNamara H, Barclay P. A reply. Anaesthesia. 2015 Jun;70(6):760-1. doi: 10.1111/anae.13128. No abstract available.</citation>
    <PMID>25959192</PMID>
  </reference>
  <reference>
    <citation>Collins PW, Cannings-John R, Bruynseels D, Mallaiah S, Dick J, Elton C, Weeks AD, Sanders J, Aawar N, Townson J, Hood K, Hall JE, Collis RE. Viscoelastometric-guided early fibrinogen concentrate replacement during postpartum haemorrhage: OBS2, a double-blind randomized controlled trial. Br J Anaesth. 2017 Sep 1;119(3):411-421. doi: 10.1093/bja/aex181.</citation>
    <PMID>28969312</PMID>
  </reference>
  <reference>
    <citation>Wikkelso AJ, Edwards HM, Afshari A, Stensballe J, Langhoff-Roos J, Albrechtsen C, Ekelund K, Hanke G, Secher EL, Sharif HF, Pedersen LM, Troelstrup A, Lauenborg J, Mitchell AU, Fuhrmann L, Svare J, Madsen MG, Bodker B, Moller AM; FIB-PPH trial group. Pre-emptive treatment with fibrinogen concentrate for postpartum haemorrhage: randomized controlled trial. Br J Anaesth. 2015 Apr;114(4):623-33. doi: 10.1093/bja/aeu444. Epub 2015 Jan 13.</citation>
    <PMID>25586727</PMID>
  </reference>
  <reference>
    <citation>Snegovskikh D, Souza D, Walton Z, Dai F, Rachler R, Garay A, Snegovskikh VV, Braveman FR, Norwitz ER. Point-of-care viscoelastic testing improves the outcome of pregnancies complicated by severe postpartum hemorrhage. J Clin Anesth. 2018 Feb;44:50-56. doi: 10.1016/j.jclinane.2017.10.003. Epub 2017 Nov 7. Erratum In: J Clin Anesth. 2018 Apr 15;48:8.</citation>
    <PMID>29121548</PMID>
  </reference>
  <reference>
    <citation>Olde Engberink RH, Kuiper GJ, Wetzels RJ, Nelemans PJ, Lance MD, Beckers EA, Henskens YM. Rapid and correct prediction of thrombocytopenia and hypofibrinogenemia with rotational thromboelastometry in cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):210-6. doi: 10.1053/j.jvca.2013.12.004.</citation>
    <PMID>24630470</PMID>
  </reference>
  <reference>
    <citation>Song JG, Jeong SM, Jun IG, Lee HM, Hwang GS. Five-minute parameter of thromboelastometry is sufficient to detect thrombocytopenia and hypofibrinogenaemia in patients undergoing liver transplantation. Br J Anaesth. 2014 Feb;112(2):290-7. doi: 10.1093/bja/aet325. Epub 2013 Sep 24.</citation>
    <PMID>24065728</PMID>
  </reference>
  <reference>
    <citation>Collins PW, Lilley G, Bruynseels D, Laurent DB, Cannings-John R, Precious E, Hamlyn V, Sanders J, Alikhan R, Rayment R, Rees A, Kaye A, Hall JE, Paranjothy S, Weeks A, Collis RE. Fibrin-based clot formation as an early and rapid biomarker for progression of postpartum hemorrhage: a prospective study. Blood. 2014 Sep 11;124(11):1727-36. doi: 10.1182/blood-2014-04-567891. Epub 2014 Jul 14.</citation>
    <PMID>25024304</PMID>
  </reference>
  <reference>
    <citation>Hagemo JS, Christiaans SC, Stanworth SJ, Brohi K, Johansson PI, Goslings JC, Naess PA, Gaarder C. Detection of acute traumatic coagulopathy and massive transfusion requirements by means of rotational thromboelastometry: an international prospective validation study. Crit Care. 2015 Mar 23;19(1):97. doi: 10.1186/s13054-015-0823-y.</citation>
    <PMID>25888032</PMID>
  </reference>
  <reference>
    <citation>Baksaas-Aasen K, Van Dieren S, Balvers K, Juffermans NP, Naess PA, Rourke C, Eaglestone S, Ostrowski SR, Stensballe J, Stanworth S, Maegele M, Goslings JC, Johansson PI, Brohi K, Gaarder C; TACTIC/INTRN collaborators. Data-driven Development of ROTEM and TEG Algorithms for the Management of Trauma Hemorrhage: A Prospective Observational Multicenter Study. Ann Surg. 2019 Dec;270(6):1178-1185. doi: 10.1097/SLA.0000000000002825.</citation>
    <PMID>29794847</PMID>
  </reference>
  <reference>
    <citation>Mace H, Lightfoot N, McCluskey S, Selby R, Roy D, Timoumi T, Karkouti K. Validity of Thromboelastometry for Rapid Assessment of Fibrinogen Levels in Heparinized Samples During Cardiac Surgery: A Retrospective, Single-center, Observational Study. J Cardiothorac Vasc Anesth. 2016 Jan;30(1):90-5. doi: 10.1053/j.jvca.2015.04.030. Epub 2015 May 5.</citation>
    <PMID>26296822</PMID>
  </reference>
  <results_reference>
    <citation>Perez-Calatayud AA, Briones-Garduno JC, Rojas-Arellano ML. [Use of thromboelastography and thromboelastometry for the rational and opportune transfusion of hemoderivatives in obstetric hemorrhage]. Ginecol Obstet Mex. 2015 Sep;83(9):569-77. Spanish.</citation>
    <PMID>26591047</PMID>
  </results_reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>June 6, 2021</last_update_submitted>
  <last_update_submitted_qc>June 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Grupo Mexicano para el Estudio de la Medicina Intensiva</investigator_affiliation>
    <investigator_full_name>Angel Augusto Perez Calatayud</investigator_full_name>
    <investigator_title>Head Intensive Care Unit Hospital de Especialidades del Niño y la Mujer Dr Felipe Nuñez Lara</investigator_title>
  </responsible_party>
  <keyword>Post Partum Hemorrhage</keyword>
  <keyword>Massive tranfusion</keyword>
  <keyword>Thromboelastometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Disseminated Intravascular Coagulation</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>no plan for sharing data has been made</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>after recruiting 50% of the participants and it will be available always</ipd_time_frame>
    <ipd_access_criteria>open</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03784794
org study id: 099/21012018/MEDCRITICAHENM
nct id: NCT03784794
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Obstetric Hemorrhage continues to be the first cause of maternal morbidity and mortality
      around the world especially in middle to low income countriesThe blood components are high
      value resources; however, its use has been shown to be a risk factor of known complications.
      The aim of the study is to compare two algorithms of coagulation management in massive
      obstetric hemorrhage Methods A randomized prospective trial single center two arms study in
      patients with severe obstetric hemorrhage (PPH > 1000) 2 different transfusion protocols one
      guided by thromboelastometry and hemostatic drugs (protrombine complex concentrate and
      fibrinogen concentrate) and the second guided by standard coagulation test and
      hemocomponents. Sample is calculated to known variance, Analyses are intention-to-treat
      without imputation, with outcomes will be performed between groups using mixed-effects two
      level regression models. For binary outcomes, a logistic model will be used and results
      presented as adjusted odds ratios (ORs) alongside 95% confidence intervals (CIs). Count data
      will be analysed using Poisson multilevel or negative binomial models.

      Primary Outcome Parameter:

      Compare between the two protocols:

      Number of allogeneic blood products transfused intra-op, within 24h after screening and
      in-hospital (RBC, Platelets and FFP; separate and overall)

      Secondary Outcome Parameter:

      Analysis of mortality, lenth of stay admission to the ICU, hysterectomy surgical
      reintervencion, Transfuse associated circulatory overload, Transfusion associated Acute lung
      injury, health associated infection will be measured as secondary outcome.
Introduction Obstetric Hemorrhage continues to be the first cause of maternal morbidity and
      mortality around the world especially in middle to low income countries. Copying trauma
      transfusion therapies now a days algorithms have been developing for 2.1.1 transfusion in
      massive obstetric hemorrhage. Blood products, play an essential role in the management of
      these patients, either during resuscitation or definitive treatment. Early transfusion,
      defined as that required in the first 24 hours after admission, it is required in about 5%
      that enters the hospital and about 3% comes to require massive transfusion. The blood
      components are high value resources; however, its use has been shown to be a risk factor for
      infectious transfusion related immunomodulation, and noninfectious complications (TRALI,
      TACO), development of systemic inflammatory response, multiple organ failure and death. A
      liberal transfusion policy can further introduce the risk of a patient who is already
      committed.

      Patient blood management is an evidence-based, multidisciplinary approach to optimizing the
      care of patients who might need transfusion. PBM encompasses all aspects of patient
      evaluation and clinical management surrounding the transfusion decision-making process,
      including the application of appropriate indications, as well as minimization of blood loss
      and optimization of patient red cell mass.

      The aim of the study is to compare two algorithms of coagulation management in massive
      obstetric hemorrhage Methods A randomized prospective trial single center two arms study in
      patients with severe obstetric hemorrhage (PPH > 1000) 2 different transfusion protocols one
      guided by thromboelastometry and hemostatic drugs (protrombine complex concentrate and
      fibrinogen concentrate) and the second guided by standard coagulation test and
      hemocomponents.

      Randomization for the patients will be made for every obstetric patient that enters the
      obstetric ward for attention of partum, and will be asked to sign consent, and the patients
      will be selected for each group of the study. Only does that have severe PPH will be entering
      the protocol with the algorithm for management previously selected. Demographic
      caracteristics will include Ethnicity, Body weight (KG), body height (CM) and BMI at hospital
      admission, Previous deliveries, Previous Caesarean section, Pre-eclampsia during pregnancy,
      History of obstetric hemorrhage, History of other kind of hemorrhage, Onset of labor
      (spontaneous, induced, no labor) Multiple gestation (singleton, twins, triplet) Reported
      cause of obstetric hemorrhage (placenta previa, placenta accreta, placenta abruption,
      retained placenta, uterine atony, trauma, surgical bleeding Mode of delivery (spontaneous
      vaginal, instrumental vaginal , elective Caesarean section, non-elective Caesarean section)
      Baseline Hb, Hct, Plt count, Fibrinogen (Clauss), PT/INR, PTT (at hospital admission)
      Estimated blood loss at study entry (ML).

      Treatment algorithms are evidence based and the management of coagulopathy is based on treat
      first what kills fist (ATLS proposal)

      Group A:

      THROMBOELASTOMETRY-GUIDED ALGORITHM FIBRINOGEN CONCENTRATE FIBTEM A5 < 12 MM AND EXTEM A5 <
      40 MM FIBTEM A5 = 9-11 MM → 2 G FIBRINOGEN CONC. (25 MG/KG); FIBTEM A5 = 4-8 MM → 4 G
      FIBRINOGEN CONC. (50 MG/KG); FIBTEM A5 < 4 MM → 6 G FIBRINOGEN CONC. (75 MG/KG) GOAL: FIBTEM
      A5: 12-16 MM PLATELETS EXTEM A5 < 40 MM AND FIBTEM A5 ≥ 12 MM EXTEM A5 < 40 MM → 1 PLATELET
      POOL OR APHERESIS; EXTEM A5 < 30 MM → 2 PLATELET POOL OR APHERESIS GOAL: EXTEM A5: 40-50 MM
      PROTROMBIN COMPLEX CONCENTRATE EXTEM CT > 80 SEC AND FIBTEM A5 ≥ 8 MM 4F-PCC 20 IU/KG (F II,
      VII, IX and X) GOAL: EXTEM CT ≤ 80 SEC NO INTERVENTION FIBTEM A5 ≥ 12 MM AND EXTEM A5 ≥ 40 MM
      AND EXTEM CT > 80 SEC NO FIBRINOGEN, CRYO, PLATELETS, 4-PCC, FFP; TRANSFUSE RBC IF Hb < 7
      G/DL GOAL: Hb > 7.5 G/DL

      Group B RATIO / STANDRAD LAB TEST-GUIDED ALGORITHM CRYOPRECIPITATE FIBRINOGEN (CLAUSS) < 250
      MG/DL FIB 200-250 MG/DL → CRYOS, PACK OF 10 (25 MG/KG); FIB 100-200 MG/DL → CRYOS, PACK OF 20
      (50 MG/KG); FIB < 100 MG/DL → CRYOS, PACK OF 30 (75 MG/KG) GOAL: FIB > 250 MG/DL PLATELETS
      PLATELET COUNT < 100/µL PLT < 100/µL → 1 PLATELET POOL OR APHERESIS; PLT > 50/µL → 2 PLATELET
      POOL OR APHERESIS GOAL: PLT COUNT > 100/µL FRESH FROZEN PLASMA TP AND/OR TTP PATHOLOGICAL
      INR, 2.0-4.0 → FFP 20 ML/KG GOAL: TP AND TTP NORMAL AND INR < 2.0 NO LAB RESULTS AVAILABLE
      TRANSFUSE RED BLOOD CELLS IF Hb < 7 G/DL; GIVE 1 UNIT FFP EVERY 2 UNITS OF RBC TRANSFUSED
      GOAL: Hb > 7.5 G/DL Statistical analysis Sample is calculated to known variance. The
      investigators calculated that 100 women will be needed to provide 80% power at the two-sided
      5% level to detect a difference of total allogeneic units between groups. With a total of 100
      patients 50 in each arm, with a first revision of results after recruiting 50 patients (25 in
      each arm). Analyses are intention-to-treat without imputation, with outcomes will be
      performed between groups using mixed-effects two level regression models. For binary
      outcomes, a logistic model will be used and results presented as adjusted odds ratios (ORs)
      alongside 95% confidence intervals (CIs). For continuous outcomes, a linear regression model
      will be performed and results presented as difference in adjusted means (arm A vs arm B)
      alongside 95% CIs. Count data will be analysed using Poisson multilevel or negative binomial
      models if over-dispersion is evident and presented as incident rate ratios (IRRs).

      Objectives

      Primary Outcome Parameter:

      Compare between the two protocols:

      Number of allogeneic blood products transfused intra-op, within 24h after screening and
      in-hospital (RBC, Platelets and FFP; separate and overall)

      Secondary Outcome Parameter:

      Compare between the two arms Number of packs of Cryo (pack of 5 ~ 1 G Fibrinogen), Fibrinogen
      Concentrate (G), and PCC (500 UI) administered intra-op, within 24h after screening and
      in-hospital Incidence ≥ 5 U RBC transfused (first 24h after screening) Incidence ≥ 10 U RBC
      transfused (first 24h after screening) Incidence of RBC, Platelets, FFP, Cryo, Fibrinogen
      Concentrate, and PCC transfusion/administration (intra-op, first 24h and in-hospital) Total
      volume of blood products and coagulation factor concentrates transfused/administered
      (intra-op, first 24h and in-hospital) Infusion: Crystalloid (ML) and Colloids (Type; ML)
      intra-op and within 24h after screening Overall estimated blood loss (EBL, ML) Time to
      bleeding control (time from study entry to last hemostatic intervention/transfusion)
      Incidence of coagulopathy (detected by thromboelastometry or standard coagulation laboratory
      tests) Incidence of hysterectomy Incidence of re-surgery Incidence of TACO Incidence of TRALI
      Incidence of surgical site infection or sepsis Incidence of ICU admission Length of stay
      (LOS) at ICU and hospital In-hospital mortality First post-op Hb, Hct, Plt count, Fibrinogen
      (Clauss), PT, INR, PTT (recovery room or ICU) Last Hb, Hct, Plt count, Fibrinogen (Clauss),
      PT, INR, PTT before discharge from hospital Total acquisition costs of allogeneic blood
      products and coagulation factor concentrates HYPOTHESIS. The algorithm guided by ROTEM plus
      the use of hemostatic drugs, are more efficient for the reversion of coagulopathy due to
      obstetric hemorrhage, than the standard treatment group, decrases the risk of development
      known complications, decreases the need of blood transfusions, decreases morbidity and
      mortality associated to PPH, length of stay, admissions to the intensive care unit and days
      of mechanical ventilation. Without a significant increase in costs.

      RELEVANCE AND EXPECTATIONS To offer a safe alternative in the treatment of severe obstetric
      hemorrhage, which reduces the risk of transfusion associated complications,
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group A Fibrinogen Concentrate, Protrombin Complex Concentrate, trhromboelastometry guided Group B Cryoprecipitates, fresh frozen plasma, standard coagulation lab test
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Blood products transfused
time frame: 24 hrs
description: Number of allogeneic blood products transfused intra-op, within 24h after screening and in-hospital (RBC, Platelets and FFP; separate and overall)
measure: Number of hemocomponents or fibrinogen concentrates needed to treat hypofibrinogenemia
time frame: day 0 to day 15
description: Number of packs of Cryo (pack of 5 ~ 1 G Fibrinogen), Fibrinogen Concentrate (G), and PCC (500 UI) administered intra-operating
measure: Incidence of Red Blood Cells transfusion (RBC)
time frame: day 0 to day 15
description: Incidence ≥ 5 U RBC transfused
measure: Incidence of Massive Red Blood Cells transfusion (RBC)
time frame: day 0 to day 15
description: Incidence ≥ 10 U RBC transfused (first 24h after screening)
measure: estimated blood loss
time frame: day 0 to day 15
description: Overall estimated blood loss (EBL, ML)
measure: Time to bleeding control
time frame: 24 hrs
description: time from study entry to last hemostatic intervention/transfusion
measure: Incidence of coagulopathy
time frame: day 0 to day 15
description: detected by thromboelastometry or standard coagulation laboratory tests
measure: Incidence of hysterectomy
time frame: day 0 to day 15
description: number of obstetric hysterectomy for bleeding control
measure: Incidence of re-surgery
time frame: day 0 to day 15
description: number of procedures necessary for bleeding control
measure: Incidence of Transfused associated circulatory overload
time frame: day 0 to day 15
description: number of patients with transfused associated circulatory overload
measure: Incidence of surgical site infection or sepsis
time frame: day 0 to day 15
description: number of patients that developed health care related infections or sepsis
measure: Incidence of ICU admission
time frame: day 0 to day 15
description: number of patients that require admission to the ICU for complications related to hipovolemic shock
measure: In-hospital mortality
time frame: day 0 to day 15
description: number of deaths
arm group label: Thromboelastometry
arm group type: Experimental
description: Decision to treat will be guided with thromboelastometry results, for fribrinogen deficiency the investigators will treat with fibrinogen concentrate (human), for correction of factor deficiency Prothrombin Complex Concentrates, Platelets with the use of platelets and Red Blood Cells for correcting hemoglobin levels
arm group label: STANDARD COAGULATION TEST ALGORITHM
arm group type: Active Comparator
description: Decision to treat will be guided by standard cogulation lab test (Thrombine time, Active Thromboplastine time, Clauss fibrinogen, platelets count etc) for fribrinogen deficiency the investigators will treat with cryoprecipitates, for correction of factor deficiency fresh frozen plasma, Platelets with the use of platelets and Red Blood Cells for correcting hemoglobin levels
intervention type: Diagnostic Test
intervention name: Thromboelastometry
description: devices generate output by transducing changes in the viscoelastic strength of a small sample of clotting blood (300 µl) to which a constant rotational force is applied. These point of care devices allow visual assessment of blood coagulation from clot formation, through propagation, and stabilization, until clot dissolution. Computer analysis of the output allows sophisticated clot formation/dissolution kinetics and clot strength data to be generated
arm group label: Thromboelastometry
other name: ROTEM
intervention type: Diagnostic Test
intervention name: Standard Coagulation Test
description: coagulation tests, such as the prothrombin time (PT), activated partial thromboplastin time (aPTT), and thrombin time (TT), to assess blood clotting function in patients. Clauss Fibrinogen.
arm group label: STANDARD COAGULATION TEST ALGORITHM
other name: blood coagulation test
intervention type: Drug
intervention name: Fibrinogen Concentrate Human
description: To treat acquired fribinogen deficiency investigators will treat with the following doses FIBTEM A5 = 9-11 MM a 2 G FIBRINOGEN CONC. (25 MG/KG); FIBTEM A5 = 4-8 MM a 4 G FIBRINOGEN CONC. (50 MG/KG); FIBTEM A5 < 4 MM a 6 G FIBRINOGEN CONC. (75 MG/KG)
arm group label: Thromboelastometry
other name: Chlotafact
intervention type: Drug
intervention name: Prothrombin Complex Concentrates
description: to treat acquired factor deficiency investigators will treat as follows PROTROMBIN COMPLEX CONCENTRATE EXTEM CT > 80 SEC AND FIBTEM A5 ≥ 8 MM 4F-PCC 20 IU/KG (F II, VII, IX and X) GOAL: EXTEM CT ≤ 80 SEC
arm group label: Thromboelastometry
other name: Confidex
intervention type: Other
intervention name: Platelets
description: PLATELETS EXTEM A5 < 40 MM AND FIBTEM A5 ≥ 12 MM EXTEM A5 < 40 MM → 1 PLATELET POOL OR APHERESIS; EXTEM A5 < 30 MM → 2 PLATELET POOL OR APHERESIS GOAL: EXTEM A5: 40-50 MM or PLATELET COUNT < 100/µL PLT < 100/µL → 1 PLATELET POOL OR APHERESIS; PLT > 50/µL → 2 PLATELET POOL OR APHERESIS GOAL: PLT COUNT > 100/µL
arm group label: STANDARD COAGULATION TEST ALGORITHM
arm group label: Thromboelastometry
intervention type: Other
intervention name: Red Blood Cells
description: Transfuce Red Blood Cells if Hemoglobine levels < 7 G/DL;
1 unit of FFP for every unit of RBC Transfused GOAL: Hb > 7.5 G/DL
arm group label: STANDARD COAGULATION TEST ALGORITHM
arm group label: Thromboelastometry
other name: RBC
intervention type: Other
intervention name: Fresh Frozen Plasma
description: FRESH FROZEN PLASMA TP AND/OR TTP PATHOLOGICAL INR, 2.0-4.0 → FFP 20 ML/KG GOAL: TP AND TTP NORMAL AND INR < 2.0
arm group label: STANDARD COAGULATION TEST ALGORITHM
intervention type: Other
intervention name: cryoprecipitates
description: FIBRINOGEN (CLAUSS) < 250 MG/DL FIB 200-250 MG/DL → CRYOS, PACK OF 10 (25 MG/KG); FIB 100-200 MG/DL → CRYOS, PACK OF 20 (50 MG/KG); FIB < 100 MG/DL → CRYOS, PACK OF 30 (75 MG/KG) GOAL: FIB > 250 MG/DL
arm group label: STANDARD COAGULATION TEST ALGORITHM
criteria: 
gender: Female
gender based: Yes
gender description: all female patients with severe obstetric hemorrhage (more than 1000 ml of estimated blood loss)
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Angel Augusto Perez Calatayud, M.D.
role: Principal Investigator
affiliation: Head Obstetric ICU
facility: 
country: Mexico
citation: Mallaiah S, Barclay P, Harrod I, Chevannes C, Bhalla A. Introduction of an algorithm for ROTEM-guided fibrinogen concentrate administration in major obstetric haemorrhage. Anaesthesia. 2015 Feb;70(2):166-75. doi: 10.1111/anae.12859. Epub 2014 Oct 7. Erratum In: Anaesthesia. 2015 Nov;70(11):1334.
PMID: 25289791
citation: Mallaiah S, Chevannes C, McNamara H, Barclay P. A reply. Anaesthesia. 2015 Jun;70(6):760-1. doi: 10.1111/anae.13128. No abstract available.
PMID: 25959192
citation: Collins PW, Cannings-John R, Bruynseels D, Mallaiah S, Dick J, Elton C, Weeks AD, Sanders J, Aawar N, Townson J, Hood K, Hall JE, Collis RE. Viscoelastometric-guided early fibrinogen concentrate replacement during postpartum haemorrhage: OBS2, a double-blind randomized controlled trial. Br J Anaesth. 2017 Sep 1;119(3):411-421. doi: 10.1093/bja/aex181.
PMID: 28969312
citation: Wikkelso AJ, Edwards HM, Afshari A, Stensballe J, Langhoff-Roos J, Albrechtsen C, Ekelund K, Hanke G, Secher EL, Sharif HF, Pedersen LM, Troelstrup A, Lauenborg J, Mitchell AU, Fuhrmann L, Svare J, Madsen MG, Bodker B, Moller AM; FIB-PPH trial group. Pre-emptive treatment with fibrinogen concentrate for postpartum haemorrhage: randomized controlled trial. Br J Anaesth. 2015 Apr;114(4):623-33. doi: 10.1093/bja/aeu444. Epub 2015 Jan 13.
PMID: 25586727
citation: Snegovskikh D, Souza D, Walton Z, Dai F, Rachler R, Garay A, Snegovskikh VV, Braveman FR, Norwitz ER. Point-of-care viscoelastic testing improves the outcome of pregnancies complicated by severe postpartum hemorrhage. J Clin Anesth. 2018 Feb;44:50-56. doi: 10.1016/j.jclinane.2017.10.003. Epub 2017 Nov 7. Erratum In: J Clin Anesth. 2018 Apr 15;48:8.
PMID: 29121548
citation: Olde Engberink RH, Kuiper GJ, Wetzels RJ, Nelemans PJ, Lance MD, Beckers EA, Henskens YM. Rapid and correct prediction of thrombocytopenia and hypofibrinogenemia with rotational thromboelastometry in cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):210-6. doi: 10.1053/j.jvca.2013.12.004.
PMID: 24630470
citation: Song JG, Jeong SM, Jun IG, Lee HM, Hwang GS. Five-minute parameter of thromboelastometry is sufficient to detect thrombocytopenia and hypofibrinogenaemia in patients undergoing liver transplantation. Br J Anaesth. 2014 Feb;112(2):290-7. doi: 10.1093/bja/aet325. Epub 2013 Sep 24.
PMID: 24065728
citation: Collins PW, Lilley G, Bruynseels D, Laurent DB, Cannings-John R, Precious E, Hamlyn V, Sanders J, Alikhan R, Rayment R, Rees A, Kaye A, Hall JE, Paranjothy S, Weeks A, Collis RE. Fibrin-based clot formation as an early and rapid biomarker for progression of postpartum hemorrhage: a prospective study. Blood. 2014 Sep 11;124(11):1727-36. doi: 10.1182/blood-2014-04-567891. Epub 2014 Jul 14.
PMID: 25024304
citation: Hagemo JS, Christiaans SC, Stanworth SJ, Brohi K, Johansson PI, Goslings JC, Naess PA, Gaarder C. Detection of acute traumatic coagulopathy and massive transfusion requirements by means of rotational thromboelastometry: an international prospective validation study. Crit Care. 2015 Mar 23;19(1):97. doi: 10.1186/s13054-015-0823-y.
PMID: 25888032
citation: Baksaas-Aasen K, Van Dieren S, Balvers K, Juffermans NP, Naess PA, Rourke C, Eaglestone S, Ostrowski SR, Stensballe J, Stanworth S, Maegele M, Goslings JC, Johansson PI, Brohi K, Gaarder C; TACTIC/INTRN collaborators. Data-driven Development of ROTEM and TEG Algorithms for the Management of Trauma Hemorrhage: A Prospective Observational Multicenter Study. Ann Surg. 2019 Dec;270(6):1178-1185. doi: 10.1097/SLA.0000000000002825.
PMID: 29794847
citation: Mace H, Lightfoot N, McCluskey S, Selby R, Roy D, Timoumi T, Karkouti K. Validity of Thromboelastometry for Rapid Assessment of Fibrinogen Levels in Heparinized Samples During Cardiac Surgery: A Retrospective, Single-center, Observational Study. J Cardiothorac Vasc Anesth. 2016 Jan;30(1):90-5. doi: 10.1053/j.jvca.2015.04.030. Epub 2015 May 5.
PMID: 26296822
citation: Perez-Calatayud AA, Briones-Garduno JC, Rojas-Arellano ML. [Use of thromboelastography and thromboelastometry for the rational and opportune transfusion of hemoderivatives in obstetric hemorrhage]. Ginecol Obstet Mex. 2015 Sep;83(9):569-77. Spanish.
PMID: 26591047
responsible party type: Sponsor-Investigator
investigator affiliation: Grupo Mexicano para el Estudio de la Medicina Intensiva
investigator full name: Angel Augusto Perez Calatayud
investigator title: Head Intensive Care Unit Hospital de Especialidades del Niño y la Mujer Dr Felipe Nuñez Lara
mesh term: Postpartum Hemorrhage
mesh term: Disseminated Intravascular Coagulation
mesh term: Hemorrhage
mesh term: Thrombin
sharing ipd: Yes
ipd description: no plan for sharing data has been made
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: after recruiting 50% of the participants and it will be available always
ipd access criteria: open