Fibrinogen Concentrate in Isolated Traumatic Brain Injury

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03304899

Enrollment

Registered

2017-10-09

Start date

2018-10-23

Completion date

2020-01-21

Last updated

2019-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage, Traumatic Brain Injury

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.

Interventions

DRUGRiaSTAP 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))

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Iran

Contacts

Primary ContactMahdi Vahidian, Student

Mehdivahid2@yahoo.com+989103374626

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026