Back to resultsFibrinogen Concentrate in Isolated Traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury, Hemorrhage
Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
RiaSTAP Injectable Product
Sponsored by
About this trial
This is an interventional prevention trial for Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- Patients with severe isolated traumatic brain injury.
Exclusion Criteria:
- Severe abdomen or extremities trauma.
- Severe bleeding from abdomen or extremities.
- Congenital coagulopathy (Hemophilia, protein S and C deficiency, Factor 5 Leiden deficiency and ...).
- Warfarin, Heparin, Enoxaparin, Dabigatran and other anticoagulation drugs consumption.
Sites / Locations
- Isfahan university of medical science.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Case group
Control group
Arm 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))
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 ...).
Outcomes
Primary Outcome Measures
Mortality rate.
Mortality rate after injection of fibrinogen concentrate.
Average of serum fibrinogen level.
Average of serum fibrinogen level in iTBI patient.
The effect of early fibrinogen on post trauma bleeding (Intracranial hemorrhage).
The need to packed cell, FFP, Platelete.
Secondary Outcome Measures
The complications that related to fibrinogen concentrate.
like DVT, PTE, MI.by measurement of serum D-dimer for DVT and PTE and serum Troponin C for MI.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03304899
Brief Title
Fibrinogen Concentrate in Isolated Traumatic Brain Injury
Official Title
Early Fibrinogen Concentrate in Isolated Traumatic Brain Injury and the Effect on Post Bleeding & Complications
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
December 21, 2019 (Anticipated)
Study Completion Date
January 21, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leila Dehghani
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Hemorrhage
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Case group
Arm Type
Experimental
Arm 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 Title
Control group
Arm Type
Active Comparator
Arm 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(s)
RiaSTAP Injectable Product
Intervention 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))
Primary Outcome Measure Information:
Title
Mortality rate.
Description
Mortality rate after injection of fibrinogen concentrate.
Time Frame
Until 90 days after admission.
Title
Average of serum fibrinogen level.
Description
Average of serum fibrinogen level in iTBI patient.
Time Frame
Immediately after admission.
Title
The effect of early fibrinogen on post trauma bleeding (Intracranial hemorrhage).
Description
The need to packed cell, FFP, Platelete.
Time Frame
2, 6, 24, 72 hours and 30 , 90 days after admission.
Secondary Outcome Measure Information:
Title
The complications that related to fibrinogen concentrate.
Description
like DVT, PTE, MI.by measurement of serum D-dimer for DVT and PTE and serum Troponin C for MI.
Time Frame
until 90 days after admission.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with severe isolated traumatic brain injury.
Exclusion Criteria:
Severe abdomen or extremities trauma.
Severe bleeding from abdomen or extremities.
Congenital coagulopathy (Hemophilia, protein S and C deficiency, Factor 5 Leiden deficiency and ...).
Warfarin, Heparin, Enoxaparin, Dabigatran and other anticoagulation drugs consumption.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahdi Vahidian, Student
Phone
+989103374626
Email
Mehdivahid2@yahoo.com
Facility Information:
Facility Name
Isfahan university of medical science.
City
Isfahan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahdi Vahidian, student
Phone
+989103374626
Email
Mehdivahid2@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Fibrinogen Concentrate in Isolated Traumatic Brain Injury
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