<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/NCT03266432</url>
  </required_header>
  <id_info>
    <org_study_id>thromboelastometryDIC</org_study_id>
    <nct_id>NCT03266432</nct_id>
  </id_info>
  <brief_title>Thromboelastometry Guided DIC Prevention After Cesarean Section in Pregnant Women With Placenta Previa</brief_title>
  <acronym>DIC</acronym>
  <official_title>Thromboelastometry Guided Disseminated Intravascular Coagulation Prevention After Cesarean Section in Pregnant Women With Placenta Previa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the use of thromboelastometry for early identification of the underlying&#xD;
      coagulopathy and to guide individualized transfusion therapy to prevent DIC development&#xD;
      during ICU stay after cesarean section in women with placenta previa who require a massive&#xD;
      blood transfusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Placenta previa is defined as complete or partial implantation of the placenta in the lower&#xD;
      segment of the uterus, Patients present with bleeding per vagina occurring usually in the&#xD;
      second and third trimester. Bleeding in placenta previa is associated with maternal morbidity&#xD;
      and mortality. Transfusion therapy is integral in the acute management of major obstetric&#xD;
      hemorrhage. The most important pregnancy related condition leading to bleeding with high&#xD;
      mortality and morbidity rates is DIC. Patients exhibit a tendency for severe bleeding&#xD;
      associated with the consumption of platelets and coagulation factors. Massive blood&#xD;
      transfusions are listed as the main maternal morbidity indicators6.Therefore, early detection&#xD;
      of these predictors of DIC and timely intervention of this life-threatening condition is very&#xD;
      important. DIC is a clinical-laboratory diagnosis, and laboratory changes need to be&#xD;
      interpreted with knowledge of the patient's underlying disorder. Several laboratory&#xD;
      parameters are analyzed together as part of a diagnostic algorithm that includes: Prothrombin&#xD;
      time (PT), Activated partial thromboplastin time (aPTT), the platelet count, fibrinogen&#xD;
      level, and a marker of fibrin degradation, e.g., D-dimer or the soluble fibrin monomer (SFM)&#xD;
      8. None of these markers are taken in isolation, and a combination of results at different&#xD;
      time points is particularly helpful in determining the presence of DIC, owing to the&#xD;
      multifaceted nature of DIC9, These reasons highlight a strong need for the development of a&#xD;
      point-of-care testing system to accurately and reliably diagnose DIC. Thromboelastography&#xD;
      (TEM) provides an extended reflection of clot initiation, propagation, and lysis in whole&#xD;
      blood. TEM uses three tests: FIBTEM to reveal impaired fibrinogen function, INTEM to reveal&#xD;
      coagulation factor deficiency and EXTEM to reveal extrinsic pathway defects&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>prevention of Postoperative development of DIC</measure>
    <time_frame>from time of operation till 48 hours postopertive</time_frame>
    <description>prevention according to the results of thromboelastometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>prevention of Complications of massive transfusion</measure>
    <time_frame>from time of operation till 48 hours postoperative</time_frame>
    <description>hypo or hyperkalaemia, hypoc alcaemia, hypothermia and metabolic alkalosis and Length of ICU and hospital stay and In-hospital mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>from time of operation till 48 hours postoperative</time_frame>
    <description>systolic blood pressure is measured every hour from time of operation till 48 hours postoperative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diastolic blood pressure</measure>
    <time_frame>from time of operation till 48 hours postoperative</time_frame>
    <description>diastolic blood pressure is measured every hour from time of operation till 48 hours postoperative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>from time of operation till 48 hours postoperative</time_frame>
    <description>heart rate is recorded every hour from time of operation till 48 hours</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>DIC Syndrome</condition>
  <arm_group>
    <arm_group_label>60 pregnant women</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>60 pregnant women diagnosed with placenta previa will take from them 3 blood samples : one pre intervention and two samples postintervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood samples</intervention_name>
    <description>three blood samples : first one pre intervention and the other two blood samples post-intervention</description>
    <arm_group_label>60 pregnant women</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA physical status I or II&#xD;
&#xD;
          -  Age: ≥ 18 years&#xD;
&#xD;
          -  Patients with all types of placenta previa&#xD;
&#xD;
          -  Eligible for general anesthesia&#xD;
&#xD;
          -  Elective cesarean section&#xD;
&#xD;
          -  Singleton term pregnancy&#xD;
&#xD;
          -  Normal coagulation profile: prothrombin time (PT), activated partial thromboplastin&#xD;
             time (aPTT), the platelet count, fibrinogen level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parturient refusal&#xD;
&#xD;
          -  Known coagulopathy&#xD;
&#xD;
          -  Women with a history of cardiac, respiratory, renal, neurologic or endocrine diseases.&#xD;
&#xD;
          -  Eclampsia and preeclampsia&#xD;
&#xD;
          -  Emergency surgeries&#xD;
&#xD;
          -  Foetal abnormalities&#xD;
&#xD;
          -  Drug induced thrombocytopenia as antibiotics&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ragaa Ahmed Herdan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut university hopitals</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed kilany, Master</last_name>
    <phone>00201090030029</phone>
    <email>mohamedkelany@aun.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assiut university hospitals</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alaa Mohamed Ahmed Attia, MD</last_name>
      <phone>01099923117</phone>
      <email>alaa.atya@med.au.edu.eg</email>
    </contact>
    <investigator>
      <last_name>Nawal Abdel-aziz Jadel-Rab Abdullah, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alaa Mohamed Ahmed Attia, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>ragaa Ahmed Herdan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>July 9, 2019</last_update_submitted>
  <last_update_submitted_qc>July 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed Kilany</investigator_full_name>
    <investigator_title>Assistant lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Placenta Previa</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03266432
org study id: thromboelastometryDIC
nct id: NCT03266432
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Evaluation of the use of thromboelastometry for early identification of the underlying
      coagulopathy and to guide individualized transfusion therapy to prevent DIC development
      during ICU stay after cesarean section in women with placenta previa who require a massive
      blood transfusion.
Placenta previa is defined as complete or partial implantation of the placenta in the lower
      segment of the uterus, Patients present with bleeding per vagina occurring usually in the
      second and third trimester. Bleeding in placenta previa is associated with maternal morbidity
      and mortality. Transfusion therapy is integral in the acute management of major obstetric
      hemorrhage. The most important pregnancy related condition leading to bleeding with high
      mortality and morbidity rates is DIC. Patients exhibit a tendency for severe bleeding
      associated with the consumption of platelets and coagulation factors. Massive blood
      transfusions are listed as the main maternal morbidity indicators6.Therefore, early detection
      of these predictors of DIC and timely intervention of this life-threatening condition is very
      important. DIC is a clinical-laboratory diagnosis, and laboratory changes need to be
      interpreted with knowledge of the patient's underlying disorder. Several laboratory
      parameters are analyzed together as part of a diagnostic algorithm that includes: Prothrombin
      time (PT), Activated partial thromboplastin time (aPTT), the platelet count, fibrinogen
      level, and a marker of fibrin degradation, e.g., D-dimer or the soluble fibrin monomer (SFM)
      8. None of these markers are taken in isolation, and a combination of results at different
      time points is particularly helpful in determining the presence of DIC, owing to the
      multifaceted nature of DIC9, These reasons highlight a strong need for the development of a
      point-of-care testing system to accurately and reliably diagnose DIC. Thromboelastography
      (TEM) provides an extended reflection of clot initiation, propagation, and lysis in whole
      blood. TEM uses three tests: FIBTEM to reveal impaired fibrinogen function, INTEM to reveal
      coagulation factor deficiency and EXTEM to reveal extrinsic pathway defects
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: prevention of Postoperative development of DIC
time frame: from time of operation till 48 hours postopertive
description: prevention according to the results of thromboelastometry
measure: prevention of Complications of massive transfusion
time frame: from time of operation till 48 hours postoperative
description: hypo or hyperkalaemia, hypoc alcaemia, hypothermia and metabolic alkalosis and Length of ICU and hospital stay and In-hospital mortality
measure: Systolic blood pressure
time frame: from time of operation till 48 hours postoperative
description: systolic blood pressure is measured every hour from time of operation till 48 hours postoperative
measure: diastolic blood pressure
time frame: from time of operation till 48 hours postoperative
description: diastolic blood pressure is measured every hour from time of operation till 48 hours postoperative
measure: heart rate
time frame: from time of operation till 48 hours postoperative
description: heart rate is recorded every hour from time of operation till 48 hours
arm group label: 60 pregnant women
arm group type: Other
description: 60 pregnant women diagnosed with placenta previa will take from them 3 blood samples : one pre intervention and two samples postintervention
intervention type: Other
intervention name: blood samples
description: three blood samples : first one pre intervention and the other two blood samples post-intervention
arm group label: 60 pregnant women
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ragaa Ahmed Herdan, MD
role: Principal Investigator
affiliation: Assiut university hopitals
last name: Mohamed kilany, Master
phone: 00201090030029
email: mohamedkelany@aun.edu.eg
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed Kilany
investigator title: Assistant lecturer
mesh term: Placenta Previa
sharing ipd: Undecided