Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients
Phase 2
Completed
- Conditions
- TraumaAcquired Bleeding Disorder
- Interventions
- Drug: placeboDrug: activated recombinant human factor VII
- Registration Number
- NCT01563523
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Africa, Asia, Europe, Oceania and North America. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII given in conjunction with standard therapy in the treatment of massive bleeding in subjects with severe blunt and/or penetrating trauma injury.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 283
Inclusion Criteria
- Informed consent obtained from the subject and/or his/her legally authorised representative (LAR) before any trial-related activities
- Injury(ies) due to a blunt and or penetrating trauma
- Receipt of 6 units of PRBC within a 4 hour period following admittance to the trauma centre
- Receipt of 8 units of PRBC upon administration of trial drug
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Exclusion Criteria
- Prehospital cardiac arrest
- Cardiac arrest in the ER or OR
- Gunshot wound to the head
- Glasgow Coma Scale below 8
- Base deficit of above 15 mEq/l or severe acidosis
- Transfusion of 8 units or more of PRBC prior to arrival in trauma centre
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo - Activated recombinant human factor VII activated recombinant human factor VII -
- Primary Outcome Measures
Name Time Method Number of PRBC (packed red blood cells) units (allogeneic/autologous) transfused
- Secondary Outcome Measures
Name Time Method Adverse Events Changes in coagulation related parameters: APTT (activated partial thromboplastin time), fibrinogen, D-dimers, anti thrombin-III, F1+2 (prothrombin fragment 1+2) and TAT (thrombin anti thrombin complex)
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧Birmingham, United Kingdom