Fibrinogen Concentrate in Isolated Traumatic Brain Injury

Study Overview
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Brief Summary
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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.

Official Title
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Early Fibrinogen Concentrate in Isolated Traumatic Brain Injury and the Effect on Post Bleeding & Complications

Conditions
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Hemorrhage, Traumatic Brain Injury

Intervention / Treatment
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* Drug: RiaSTAP Injectable Product


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case group<br>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)) | Drug: RiaSTAP Injectable Product<br>* 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))<br>|
| Active Comparator: Control group<br>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 ...). | Drug: RiaSTAP Injectable Product<br>* 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))<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate. | Mortality rate after injection of fibrinogen concentrate. | Until 90 days after admission. | 
| Average of serum fibrinogen level. | Average of serum fibrinogen level in iTBI patient. | Immediately after admission. | 
| The effect of early fibrinogen on post trauma bleeding (Intracranial hemorrhage). | The need to packed cell, FFP, Platelete. | 2, 6, 24, 72 hours and 30 , 90 days after admission. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | until 90 days after admission. |