NCT03304899

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 9, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

October 23, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2020

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

September 9, 2017

Last Update Submit

February 26, 2019

Conditions

Traumatic Brain InjuryHemorrhage

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • The complications that related to fibrinogen concentrate.

    until 90 days after admission.

Study Arms (2)

Case group

EXPERIMENTAL

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))

Drug: RiaSTAP Injectable Product

Control group

ACTIVE COMPARATOR

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 ...).

Drug: RiaSTAP Injectable Product

Interventions

RiaSTAP Injectable ProductDRUG

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))

Case groupControl group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with severe isolated traumatic brain injury.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan university of medical science.

Isfahan, Iran

RECRUITING

MeSH Terms

Conditions

Brain Injuries, TraumaticHemorrhage

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Mahdi Vahidian, Student

CONTACT

+989103374626Mehdivahid2@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Early fibrinogen concentrate in severe isolated traumatic brain injury and the effect on post bleeding and complications.

Study Record Dates

First Submitted

September 9, 2017

First Posted

October 9, 2017

Study Start

October 23, 2018

Primary Completion

December 21, 2019

Study Completion

January 21, 2020

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

IR(1)