Effect of immediate, pre-emptive fibrinogen concentrate in patients with trauma haemorrhage needing haemostatic resuscitation - a randomized, controlled, double-blinded investigator-initiated pilot trial

Phase 1

Conditions: Trauma patients with ongoing haemorrhage
MedDRA version: 17.1Level: LLTClassification code 10005103Term: BleedingSystem Organ Class: 100000004866
MedDRA version: 17.1Level: LLTClassification code 10044461Term: TraumaSystem Organ Class: 100000004863
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2014-003978-16-DK

Lead Sponsor: Section for Transfusion Medicine, Capitol Region Blood Bank

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Trauma patient received directly from the scene of the accident AND
•Age = 18 years AND
•Initiated order of transfusion of at least one blood component within the 1st hour of arrival AND
•Predicted to need transfusion package therapy during the initial resuscitation (first 2 hours) AND
•Consent obtainable from patient or scientific guardians (independent physicians and/or next of kin)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

•Duration of > 2 hours from arrival at trauma centre OR
•Anticoagulant treatment (vitamin K antagonist, dabigatran, rivaroxiban, apixaban) OR
•Severe isolated traumatic brain injury OR
•Moribund patient with devastating injuries and expected to die within one hour of admission OR
•Withdrawal from active therapy OR
•Previously within 30 days included in a randomized trial, if known at the time of enrollment OR
•Known body weight < 55 kg OR
•Any blood product prior to inclusion

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy and safety of an immediate pre-emptive first-line treatment with fibrinogen concentrate in patients with trauma haemorrhage in need of haemostatic resuscitation.;Secondary Objective: Not applicable;Primary end point(s): •Thrombelastograph (TEG®) Functional Fibrinogen (FF) maximum amplitude (MA) in mm;Timepoint(s) of evaluation of this end point: 15 min post intervention

Secondary Outcome Measures