<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/NCT04424563</url>
  </required_header>
  <id_info>
    <org_study_id>ICU-8-20</org_study_id>
    <nct_id>NCT04424563</nct_id>
  </id_info>
  <brief_title>Activated Factor Seven in Traumatic Retro Peritoneal Hematoma</brief_title>
  <official_title>Activated Factor Seven (aFVII) Versus Aminocaproic Acid For Treatment of Traumatic Retro-Peritoneal Hematoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdul Aziz Specialist Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Abdul Aziz Specialist Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      80 patients with traumatic retro-peritoneal hematoma allocated into two groups 40 patients&#xD;
      each. Patients of Group A received aminocaproic acid while patients of group B received&#xD;
      aFVII. Number of packed RBCs given to get target Hb level and time to get this target Hb&#xD;
      level (&gt;10 gm%) recorded as indicators for control bleeding. Blood pressure, pulse, Arterial&#xD;
      blood gasses and urine output recorded as indicator for treatment of hypovolemic shock.&#xD;
      hypoxic index, chest X ray and coagulation profile used as indicator for complication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      80 patients admitted to King Abdul-Aziz Specialist Hospital in Taif, KSA between May 2017 and&#xD;
      December 2019 with polytrauma and severe retroperitoneal bleeding diagnosed by abdominal&#xD;
      computerized tomography.&#xD;
&#xD;
      King Abdelaziz research and ethical committee approved the project under heading of ethical&#xD;
      approval and heading of human and animal rights along with Helsinki Declaration.&#xD;
&#xD;
      A written consent from the patient or from their 1st degree relative was obtained if patient&#xD;
      intubated. The primary outcome of This study divided into 3 parts. 1st 0ne compare the&#xD;
      ability of both drugs to stop retroperitoneal bleeding efficiently and in shorter time for&#xD;
      these 2 measurable indicators selected in our study the number of packed RBCS needed to&#xD;
      achieve hemoglobin level (Hb) &gt; 10 gm% and the time needed to achieve this target Hb. the 2nd&#xD;
      part indicators divided into clinical indicators (blood pressure, pulse and urine output) and&#xD;
      laboratory indicators [arterial blood gases especially PH, and bicarbonate concentration&#xD;
      (HCO3)]. the 3rd part indicators PT, PTT and Platelets count were used as indicator for DIC&#xD;
      and hypoxic index and chest x ray were used as indicator for TRALI (transfusion related acute&#xD;
      lung injury).&#xD;
&#xD;
      Resuscitation done in all patients in both groups according to hospital protocol by&#xD;
      crystalloid (normal saline), colloids [plasma protein fraction-packed RBCs, fresh frozen&#xD;
      plasma], until achieve satisfactory stable vital data. All laboratory work samples were&#xD;
      collected (CBC complete blood picture, Blood chemistry included liver enzymes and kidney&#xD;
      function tests, Coagulation profile, arterial blood gasses).&#xD;
&#xD;
      Urine output collected hourly. Our study included any patient who received more than 50ml/kg&#xD;
      blood during the first 8hours after admission in order to achieved a hemoglobin level &gt;10&#xD;
      gram %, with platelet count more than 50, 000/mm3 after resuscitation and Their temperature&#xD;
      was more than 36 degree centigrade after warming. Which considered criteria needed to get&#xD;
      maximum effect from aFVII if used intravenously. Patient randomized into 2 groups, 40&#xD;
      patients in each, this done by randomization numbers. Patients of group A received&#xD;
      aminocaproic acid at dose of 4 gram slowly intravenous infusion over 1 hour and continues&#xD;
      slowly intravenous infusion 1 gram/ hour for 8 hours. While patients of group B received&#xD;
      aFVII according to the following protocol, First dose 200 microgram/kg. If patient still&#xD;
      oozing, vital data not stable and/or could not achieve and keep the target Hb (&gt;10 gm%)&#xD;
      another 2 doses of aFVII received each dose 100microgram /kg 1 hour and 3 hours apart from&#xD;
      the initial dose if needed. The exclusion criteria in our study, if patient had cardiac&#xD;
      arrest before giving aFVII, deeply comatose with Glasgow coma scale (GCS) 3/15 and pupil&#xD;
      dilated fixed.&#xD;
&#xD;
      All patient in both groups observed for 48hours and the following indicators recorded.&#xD;
&#xD;
      Indicators for efficacy of stop bleeding (number of packed RBCs needed to keep hemoglobin&#xD;
      level &gt;10 gm% and time needed to reach this target Hb).&#xD;
&#xD;
      Indicators for ability of both drugs to treatment the hemorrhagic shock and restore tissue&#xD;
      perfusion (and this assessed by clinical indicators blood pressure, pulse and urine output&#xD;
      and laboratory indicators as arterial PH and bicarbonate concentration ( HCO3) Indicators for&#xD;
      ability of both drugs to protect the patients with retroperitoneal hematoma from&#xD;
      complications of massive blood transfusion and in this 2 complications were selected the&#xD;
      disseminated intra-vascular coagulopathy (DIC) and PT, PTT, Platelets count were used as&#xD;
      indicators and (TRALI) transfusion related acute lung injury and the hypoxic index and chest&#xD;
      x ray were used as indicators. The duration of the study only two days and the data recorded&#xD;
      every 8 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 5, 2017</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 19, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Days</target_duration>
  <primary_outcome>
    <measure>stop bleeding</measure>
    <time_frame>2 days</time_frame>
    <description>efficacy of activated factor seven with aminocaproic acid in medical treatment of retroperitoneal bleeding,</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Traumatic Bleeding</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Patients of group A include 40 patients, received aminocaproic acid at dose of 4 gram slowly intravenous infusion over 1 hour and continues slowly intravenous infusion 1 gram/ hour for 8 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>While patients of group B include 40 patients, received aFVII according to the following protocol, First dose 200 microgram/kg. If patient still oozing, vital data not stable and/or could not achieve and keep the target Hb (&gt;10 gm%) another 2 doses of aFVII received each dose 100microgram /kg 1 hour and 3 hours apart from the initial dose if needed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ventilators</intervention_name>
    <description>all patients in both groups will be ventilated if shocked and no recordable blood pressure</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aminocaproic acid</intervention_name>
    <description>4 gram slowly intravenous infusion over 1 hour and continues slowly intravenous infusion 1 gram/ hour for 8 hours.</description>
    <arm_group_label>Group A</arm_group_label>
    <other_name>Amicar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Novo Seven</intervention_name>
    <description>200 microgram/kg. If patient still oozing, vital data not stable and/or could not achieve and keep the target Hb (&gt;10 gm%) another 2 doses of aFVII received</description>
    <arm_group_label>Group B</arm_group_label>
    <other_name>activated factor seven</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        80 patients admitted to King Abdul-Aziz Specialist Hospital in Taif, KSA between May 2017&#xD;
        and December 2019 with polytrauma and severe retroperitoneal bleeding diagnosed by&#xD;
        abdominal computerized tomography.&#xD;
&#xD;
        King Abdelaziz research and ethical committee approved the project under heading of ethical&#xD;
        approval and heading of human and animal rights along with Helsinki Declaration.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  severe bleeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  post arrest&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>King abd el Aziz specialist hospital</name>
      <address>
        <city>Ta'if</city>
        <zip>21944</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aminocaproic Acid</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04424563
org study id: ICU-8-20
nct id: NCT04424563
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
80 patients with traumatic retro-peritoneal hematoma allocated into two groups 40 patients
      each. Patients of Group A received aminocaproic acid while patients of group B received
      aFVII. Number of packed RBCs given to get target Hb level and time to get this target Hb
      level (>10 gm%) recorded as indicators for control bleeding. Blood pressure, pulse, Arterial
      blood gasses and urine output recorded as indicator for treatment of hypovolemic shock.
      hypoxic index, chest X ray and coagulation profile used as indicator for complication.
80 patients admitted to King Abdul-Aziz Specialist Hospital in Taif, KSA between May 2017 and
      December 2019 with polytrauma and severe retroperitoneal bleeding diagnosed by abdominal
      computerized tomography.

      King Abdelaziz research and ethical committee approved the project under heading of ethical
      approval and heading of human and animal rights along with Helsinki Declaration.

      A written consent from the patient or from their 1st degree relative was obtained if patient
      intubated. The primary outcome of This study divided into 3 parts. 1st 0ne compare the
      ability of both drugs to stop retroperitoneal bleeding efficiently and in shorter time for
      these 2 measurable indicators selected in our study the number of packed RBCS needed to
      achieve hemoglobin level (Hb) > 10 gm% and the time needed to achieve this target Hb. the 2nd
      part indicators divided into clinical indicators (blood pressure, pulse and urine output) and
      laboratory indicators [arterial blood gases especially PH, and bicarbonate concentration
      (HCO3)]. the 3rd part indicators PT, PTT and Platelets count were used as indicator for DIC
      and hypoxic index and chest x ray were used as indicator for TRALI (transfusion related acute
      lung injury).

      Resuscitation done in all patients in both groups according to hospital protocol by
      crystalloid (normal saline), colloids [plasma protein fraction-packed RBCs, fresh frozen
      plasma], until achieve satisfactory stable vital data. All laboratory work samples were
      collected (CBC complete blood picture, Blood chemistry included liver enzymes and kidney
      function tests, Coagulation profile, arterial blood gasses).

      Urine output collected hourly. Our study included any patient who received more than 50ml/kg
      blood during the first 8hours after admission in order to achieved a hemoglobin level >10
      gram %, with platelet count more than 50, 000/mm3 after resuscitation and Their temperature
      was more than 36 degree centigrade after warming. Which considered criteria needed to get
      maximum effect from aFVII if used intravenously. Patient randomized into 2 groups, 40
      patients in each, this done by randomization numbers. Patients of group A received
      aminocaproic acid at dose of 4 gram slowly intravenous infusion over 1 hour and continues
      slowly intravenous infusion 1 gram/ hour for 8 hours. While patients of group B received
      aFVII according to the following protocol, First dose 200 microgram/kg. If patient still
      oozing, vital data not stable and/or could not achieve and keep the target Hb (>10 gm%)
      another 2 doses of aFVII received each dose 100microgram /kg 1 hour and 3 hours apart from
      the initial dose if needed. The exclusion criteria in our study, if patient had cardiac
      arrest before giving aFVII, deeply comatose with Glasgow coma scale (GCS) 3/15 and pupil
      dilated fixed.

      All patient in both groups observed for 48hours and the following indicators recorded.

      Indicators for efficacy of stop bleeding (number of packed RBCs needed to keep hemoglobin
      level >10 gm% and time needed to reach this target Hb).

      Indicators for ability of both drugs to treatment the hemorrhagic shock and restore tissue
      perfusion (and this assessed by clinical indicators blood pressure, pulse and urine output
      and laboratory indicators as arterial PH and bicarbonate concentration ( HCO3) Indicators for
      ability of both drugs to protect the patients with retroperitoneal hematoma from
      complications of massive blood transfusion and in this 2 complications were selected the
      disseminated intra-vascular coagulopathy (DIC) and PT, PTT, Platelets count were used as
      indicators and (TRALI) transfusion related acute lung injury and the hypoxic index and chest
      x ray were used as indicators. The duration of the study only two days and the data recorded
      every 8 hours.
observational model: Cohort
time perspective: Prospective
measure: stop bleeding
time frame: 2 days
description: efficacy of activated factor seven with aminocaproic acid in medical treatment of retroperitoneal bleeding,
arm group label: Group A
description: Patients of group A include 40 patients, received aminocaproic acid at dose of 4 gram slowly intravenous infusion over 1 hour and continues slowly intravenous infusion 1 gram/ hour for 8 hours.
arm group label: Group B
description: While patients of group B include 40 patients, received aFVII according to the following protocol, First dose 200 microgram/kg. If patient still oozing, vital data not stable and/or could not achieve and keep the target Hb (>10 gm%) another 2 doses of aFVII received each dose 100microgram /kg 1 hour and 3 hours apart from the initial dose if needed.
intervention type: Device
intervention name: ventilators
description: all patients in both groups will be ventilated if shocked and no recordable blood pressure
arm group label: Group A
arm group label: Group B
intervention type: Drug
intervention name: aminocaproic acid
description: 4 gram slowly intravenous infusion over 1 hour and continues slowly intravenous infusion 1 gram/ hour for 8 hours.
arm group label: Group A
other name: Amicar
intervention type: Drug
intervention name: Novo Seven
description: 200 microgram/kg. If patient still oozing, vital data not stable and/or could not achieve and keep the target Hb (>10 gm%) another 2 doses of aFVII received
arm group label: Group B
other name: activated factor seven
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Saudi Arabia
responsible party type: Sponsor
mesh term: Hematoma
mesh term: Aminocaproic Acid