Fibrinogen Concentrate in Isolated Traumatic Brain Injury

Phase 1

• Conditions: Traumatic Brain Injury; Hemorrhage
• Interventions: Drug: RiaSTAP Injectable Product

• Registration Number: NCT03304899
• Lead Sponsor: Leila Dehghani

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-09
• Study First Submitted QC: 2017-10-06
• Study First Posted: 2017-10-09
• Study Start: 2018-10-23
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27
• Primary Completion: 2019-12-21
• Study Completion: 2020-01-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case group	RiaSTAP Injectable Product	Severe isolated Traumatic Brain injury patients with serum fibrinogen level under 200 mg/dl that receive Fibrinogen concentrate after common emergency resuscitation. Instruction: 1. Airway control \& breathing. 2. Circulation (Serum therapy, Epinephrine,Packed cell, FFP and ...). 3. 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))
Control group	RiaSTAP Injectable Product	Severe isolated Traumatic Brain injury patients with serum fibrinogen level under 200 mg/dl that receive common emergency resuscitation. Instruction: 1. Airway control \& breathing. 2. Circulation (Serum therapy, Epinephrine,Packed cell, FFP and ...).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The complications that related to fibrinogen concentrate.	until 90 days after admission.	like DVT, PTE, MI.by measurement of serum D-dimer for DVT and PTE and serum Troponin C for MI.

Trial Locations

Locations (1)

Isfahan university of medical science.; 🇮🇷 Isfahan, Iran, Islamic Republic of