Fibrinogen Concentrate in Isolated Traumatic Brain Injury

Leila Dehghani

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Traumatic Brain Injury; Hemorrhage

Treatments: Drug: RiaSTAP Injectable Product

Study type: Interventional

Funder types: Other

Identifiers

NCT03304899

Isfahan University

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Case group

Experimental group

Description:

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))

Treatment:

Drug: RiaSTAP Injectable Product

Control group

Active Comparator group

Description:

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 ...).

Treatment:

Drug: RiaSTAP Injectable Product