Fibrinogen Concentrate in Isolated Traumatic Brain Injury

NCT03304899 — Phase 1 / Phase 2, Unknown, 50 participants, Leila Dehghani

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

Registry	NCT03304899
Status	Unknown
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, parallel, masking: double, prevention
Enrollment	50 (Estimated)
Sponsor	Leila Dehghani (Other)
Conditions	Traumatic Brain Injury, Hemorrhage
Interventions	RiaSTAP Injectable Product (Drug)
Dates	start 2018-10-23, primary completion 2019-12-21 (estimated), completion 2020-01-21 (estimated), first posted 2017-10-09, last updated 2019-02-27
Locations	1 site in Iran

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Case group	Experimental	Drug: RiaSTAP Injectable Product	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))
Control group	Active comparator	Drug: RiaSTAP Injectable Product	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 ...).

RiaSTAP Injectable Product (Drug): 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 outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Isfahan university of medical science.	Isfahan	Iran	Recruiting

My Notes

Public

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