Fibrinogen Concentrate in Isolated Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03304899
• Other study ID #: Isfahan University
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 23, 2018
• Est. completion date: January 21, 2020

Study information

• Verified date: February 2019
• Source: Isfahan University of Medical Sciences
• Contact: Mahdi Vahidian, Student
• Phone: +989103374626
• Email: Mehdivahid2[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 21, 2020
• Est. primary completion date: December 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Hemorrhage
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Drug:
• 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))

Locations

Country	Name	City	State
Iran, Islamic Republic of	Isfahan university of medical science.	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Leila Dehghani

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate.	Mortality rate after injection of fibrinogen concentrate.	Until 90 days after admission.
Primary	Average of serum fibrinogen level.	Average of serum fibrinogen level in iTBI patient.	Immediately after admission.
Primary	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	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.