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Efficacy and Safety of Activated Recombinant Human Factor VII in Severely Injured Trauma Patients

Phase 2
Completed
Conditions
Trauma
Acquired Bleeding Disorder
Interventions
Drug: placebo
Drug: 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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placeboplacebo-
Activated recombinant human factor VIIactivated recombinant human factor VII-
Primary Outcome Measures
NameTimeMethod
Number of PRBC (packed red blood cells) units (allogeneic/autologous) transfused
Secondary Outcome Measures
NameTimeMethod
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

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