Fibrinogen Concentrate in Isolated Traumatic Brain Injury

• ClinicalTrials.gov Identifier: NCT03304899
• Recruitment Status: Unknown
• First Posted: October 9, 2017
• Last Update Posted: February 27, 2019
• Sponsor: Leila Dehghani
• Information provided by (Responsible Party): Leila Dehghani, Isfahan University of Medical Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Traumatic Brain Injury; Hemorrhage	Drug: RiaSTAP Injectable Product	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Early Fibrinogen Concentrate in Isolated Traumatic Brain Injury and the Effect on Post Bleeding & Complications
• Actual Study Start Date: October 23, 2018
• Estimated Primary Completion Date: December 21, 2019
• Estimated Study Completion Date: January 21, 2020

Arms and Interventions

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))

Outcome Measures

Primary Outcome Measures :

1. Mortality rate. [ Time Frame: Until 90 days after admission. ]
   Mortality rate after injection of fibrinogen concentrate.
2. Average of serum fibrinogen level. [ Time Frame: Immediately after admission. ]
   Average of serum fibrinogen level in iTBI patient.
3. The effect of early fibrinogen on post trauma bleeding (Intracranial hemorrhage). [ Time Frame: 2, 6, 24, 72 hours and 30 , 90 days after admission. ]
   The need to packed cell, FFP, Platelete.

Secondary Outcome Measures :

1. The complications that related to fibrinogen concentrate. [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Mahdi Vahidian, Student; +989103374626; Mehdivahid2@yahoo.com

Locations

Iran, Islamic Republic of

Isfahan university of medical science.; Recruiting

Isfahan, Iran, Islamic Republic of

Contact: Mahdi Vahidian, student +989103374626 Mehdivahid2@yahoo.com

Sponsors and Collaborators

Leila Dehghani

More Information

• Responsible Party: Leila Dehghani, Early fibrinogen concentrate in severe isolated traumatic brain injury and the effect on post bleeding and complications., Isfahan University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT03304899
• Other Study ID Numbers: Isfahan University
• First Posted: October 9, 2017
• Last Update Posted: February 27, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Hemorrhage; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Pathologic Processes