Fibrinogen Concentrate in Isolated Traumatic Brain Injury

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

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.

Study Overview

• Status: Unknown
• Conditions: Hemorrhage; Traumatic Brain Injury
• Intervention / Treatment: Drug: RiaSTAP Injectable Product

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Mahdi Vahidian, student; Phone Number: +989103374626; Email: Mehdivahid2@yahoo.com

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of
    • Recruiting
    • Isfahan university of medical science.
    • Contact: Mahdi Vahidian, student; Phone Number: +989103374626; Email: Mehdivahid2@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: Airway control & breathing.; Circulation (Serum therapy, Epinephrine,Packed cell, FFP and ...).; 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))	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))
Active Comparator: Control group; Severe isolated Traumatic Brain injury patients with serum fibrinogen level under 200 mg/dl that receive common emergency resuscitation. Instruction: Airway control & breathing.; Circulation (Serum therapy, Epinephrine,Packed cell, FFP and ...).	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))

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate.	Mortality rate after injection of fibrinogen concentrate.	Until 90 days after admission.
Average of serum fibrinogen level.	Average of serum fibrinogen level in iTBI patient.	Immediately after admission.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Leila Dehghani

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2018
• Primary Completion (Anticipated): December 21, 2019
• Study Completion (Anticipated): January 21, 2020

Study Registration Dates

• First Submitted: September 9, 2017
• First Submitted That Met QC Criteria: October 6, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Hemorrhage; Brain Injuries, Traumatic
• Other Study ID Numbers: Isfahan University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No