Fibrinogen Concentrate in Isolated Traumatic Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-23

Study Completion Date

2020-01-21

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.

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Detailed Description

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Conditions

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Traumatic Brain Injury Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Case group

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))

Group Type EXPERIMENTAL

RiaSTAP Injectable Product

Intervention Type DRUG

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))

Control group

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 ...).

Group Type ACTIVE_COMPARATOR

RiaSTAP Injectable Product

Intervention Type DRUG

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))

Interventions

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RiaSTAP Injectable Product

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))

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No