<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/NCT03304899</url>
  </required_header>
  <id_info>
    <org_study_id>Isfahan University</org_study_id>
    <nct_id>NCT03304899</nct_id>
  </id_info>
  <brief_title>Fibrinogen Concentrate in Isolated Traumatic Brain Injury</brief_title>
  <official_title>Early Fibrinogen Concentrate in Isolated Traumatic Brain Injury and the Effect on Post Bleeding &amp; Complications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Leila Dehghani</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isfahan University of Medical Sciences</source>
  <oversight_info>
    <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>
      Fibrinogen is a unique precursor of fibrin and cannot be compensated for by other coagulation&#xD;
      factors. If plasma fibrinogen concentrations are insufficient, hemostatic clots cannot be&#xD;
      formed with the appropriate firmness. In severe traumatic brain injury(TBI) patients, plasma&#xD;
      fibrinogen concentrations decrease earlier and more frequently than other coagulation&#xD;
      factors,predicting massive bleeding and death.&#xD;
&#xD;
      The purpose of this study is to try early injection of fibrinogen concentrate in severe&#xD;
      isolated traumatic brain injury and investigation the effect of it on post bleeding and&#xD;
      complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 23, 2018</start_date>
  <completion_date type="Anticipated">January 21, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 21, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality rate.</measure>
    <time_frame>Until 90 days after admission.</time_frame>
    <description>Mortality rate after injection of fibrinogen concentrate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average of serum fibrinogen level.</measure>
    <time_frame>Immediately after admission.</time_frame>
    <description>Average of serum fibrinogen level in iTBI patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The effect of early fibrinogen on post trauma bleeding (Intracranial hemorrhage).</measure>
    <time_frame>2, 6, 24, 72 hours and 30 , 90 days after admission.</time_frame>
    <description>The need to packed cell, FFP, Platelete.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The complications that related to fibrinogen concentrate.</measure>
    <time_frame>until 90 days after admission.</time_frame>
    <description>like DVT, PTE, MI.by measurement of serum D-dimer for DVT and PTE and serum Troponin C for MI.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Case group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Severe isolated Traumatic Brain injury patients with serum fibrinogen level under 200 mg/dl that receive Fibrinogen concentrate after common emergency resuscitation. Instruction:&#xD;
Airway control &amp; breathing.&#xD;
Circulation (Serum therapy, Epinephrine,Packed cell, FFP and ...).&#xD;
Fibrinogen Concentrate(IV injection): Each vial contains 1gr fibrinogen concentrate. Fibrinogen concentrate will be given until serum fibrinogen level riches to 200 mg/dl.&#xD;
Dose (mg/kg body weight) = ([Target level (mg/dL) - measured level (mg/dL)])/(1.7 (mg/dL per mg/kg body weight))</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Severe isolated Traumatic Brain injury patients with serum fibrinogen level under 200 mg/dl that receive common emergency resuscitation. Instruction:&#xD;
Airway control &amp; breathing.&#xD;
Circulation (Serum therapy, Epinephrine,Packed cell, FFP and ...).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RiaSTAP Injectable Product</intervention_name>
    <description>RiaSTAP, Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes.&#xD;
Dose (mg/kg body weight) =&#xD;
([Target level (mg/dL) - measured level (mg/dL)])/(1.7 (mg/dL per mg/kg body weight))</description>
    <arm_group_label>Case group</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with severe isolated traumatic brain injury.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe abdomen or extremities trauma.&#xD;
&#xD;
          -  Severe bleeding from abdomen or extremities.&#xD;
&#xD;
          -  Congenital coagulopathy (Hemophilia, protein S and C deficiency, Factor 5 Leiden&#xD;
             deficiency and ...).&#xD;
&#xD;
          -  Warfarin, Heparin, Enoxaparin, Dabigatran and other anticoagulation drugs consumption.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mahdi Vahidian, Student</last_name>
    <phone>+989103374626</phone>
    <email>Mehdivahid2@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Isfahan university of medical science.</name>
      <address>
        <city>Isfahan</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mahdi Vahidian, student</last_name>
      <phone>+989103374626</phone>
      <email>Mehdivahid2@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 9, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>February 26, 2019</last_update_submitted>
  <last_update_submitted_qc>February 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Isfahan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Leila Dehghani</investigator_full_name>
    <investigator_title>Early fibrinogen concentrate in severe isolated traumatic brain injury and the effect on post bleeding and complications.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT03304899
org study id: Isfahan University
nct id: NCT03304899
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Fibrinogen is a unique precursor of fibrin and cannot be compensated for by other coagulation
      factors. If plasma fibrinogen concentrations are insufficient, hemostatic clots cannot be
      formed with the appropriate firmness. In severe traumatic brain injury(TBI) patients, plasma
      fibrinogen concentrations decrease earlier and more frequently than other coagulation
      factors,predicting massive bleeding and death.

      The purpose of this study is to try early injection of fibrinogen concentrate in severe
      isolated traumatic brain injury and investigation the effect of it on post bleeding and
      complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Mortality rate.
time frame: Until 90 days after admission.
description: Mortality rate after injection of fibrinogen concentrate.
measure: Average of serum fibrinogen level.
time frame: Immediately after admission.
description: Average of serum fibrinogen level in iTBI patient.
measure: The effect of early fibrinogen on post trauma bleeding (Intracranial hemorrhage).
time frame: 2, 6, 24, 72 hours and 30 , 90 days after admission.
description: The need to packed cell, FFP, Platelete.
measure: The complications that related to fibrinogen concentrate.
time frame: until 90 days after admission.
description: like DVT, PTE, MI.by measurement of serum D-dimer for DVT and PTE and serum Troponin C for MI.
arm group label: Case group
arm group type: Experimental
description: Severe isolated Traumatic Brain injury patients with serum fibrinogen level under 200 mg/dl that receive Fibrinogen concentrate after common emergency resuscitation. Instruction:
Airway control & breathing.
Circulation (Serum therapy, Epinephrine,Packed cell, FFP and ...).
Fibrinogen Concentrate(IV injection): Each vial contains 1gr fibrinogen concentrate. Fibrinogen concentrate will be given until serum fibrinogen level riches to 200 mg/dl.
Dose (mg/kg body weight) = ([Target level (mg/dL) - measured level (mg/dL)])/(1.7 (mg/dL per mg/kg body weight))
arm group label: Control group
arm group type: Active Comparator
description: Severe isolated Traumatic Brain injury patients with serum fibrinogen level under 200 mg/dl that receive common emergency resuscitation. Instruction:
Airway control & breathing.
Circulation (Serum therapy, Epinephrine,Packed cell, FFP and ...).
intervention type: Drug
intervention name: RiaSTAP Injectable Product
description: RiaSTAP, Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes.
Dose (mg/kg body weight) =
([Target level (mg/dL) - measured level (mg/dL)])/(1.7 (mg/dL per mg/kg body weight))
arm group label: Case group
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mahdi Vahidian, Student
phone: +989103374626
email: Mehdivahid2@yahoo.com
facility: 
status: Recruiting
contact: 
country: Iran, Islamic Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Isfahan University of Medical Sciences
investigator full name: Leila Dehghani
investigator title: Early fibrinogen concentrate in severe isolated traumatic brain injury and the effect on post bleeding and complications.
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Hemorrhage
mesh term: Wounds and Injuries
sharing ipd: Undecided