A clinical trial to investigate the effects of a product, fibrinogen concentrate, to assist with rapid clotting of the blood, in patients with major bleeding caused by trauma.
- Conditions
- Trauma patients whereby the local major haemorrhage protocol has been activatedMedDRA version: 18.0 Level: LLT Classification code 10044461 Term: Trauma System Organ Class: 100000004863Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
- Registration Number
- EUCTR2015-000875-28-GB
- Lead Sponsor
- HS Blood & Transplant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
1.Written informed consent or agreement, or waiver of consent, is obtained before any study related activity
2.The participant is judged to be an adult (aged 16 years or over) and is affected by traumatic injury
3.The participant is deemed by the attending clinician to have on-going active haemorrhage with shock
AND REQUIRES:
4.activation of the local major haemorrhage protocol for management of severe blood loss and/or transfusion of emergency (Group O) red cells
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
1.The participant has been transferred from another hospital
2.The trauma team leader deems the patient inappropriate for the trial i.e. injuries deemed to be incompatible with life
3.More than 3 hours have elapsed from the time of injury
4.The participant is pregnant
5.Severe isolated TBI or unsalvageable head injury
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method