Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VIIgiven in conjunction with standard therapy in patients undergoing major orthopaedic surgery following traumatic pelvic or pelvic and acetabular fractures.

Official Title
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A Single-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Efficacy and Safety of Activated Recombinant Coagulation Factor VII (rFVIIa, NovoSeven®) in Patients With Major Fractures of Pelvis or Pelvis and Acetabulum Undergoing Repair Surgery

Conditions
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Trauma, Acquired Bleeding Disorder

Intervention / Treatment
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* Drug: activated recombinant human factor VII
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Injury due to a blunt or penetrating trauma causing pelvic or pelvic and acetabular fracture amenable to surgical reconstruction Scheduled for a semi-elective reconstruction surgery for fracture(s) of pelvis or pelvis and acetabulum, which was expected to be a large complex procedure with the potential of blood loss more than 50% of circulating blood volume Exclusion Criteria: A history of thrombosis (deep vein thrombosis, pulmonary embolism, cerebral thrombosis) Patients with severe head injuries or an abnormal computed tomography (CT) scan of the head due to head injuries Body weight exceeding 135 kg Cardiac arrest following trauma and prior to surgery Known congenital bleeding disorders Known pregnancy or positive pregnancy test at enrolment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Activated recombinant human factor VII<br> | Drug: activated recombinant human factor VII<br>* 90 mcg/kg body weight administered intravenously as a slow, bolus injection after the patients had been anaesthetised and immediately before the first skin incision. A second dose was given if an intraoperative haemoglobin was less than 8.0 g/dl after salvaged red cells (RBC) had been re-transfused<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Administered intravenously as a slow, bolus injection after the patients had been anaesthetised and immediately before the first skin incision. A second dose was given if an intraoperative haemoglobin was less than 8.0 g/dl after salvaged red cells (RBC) had been re-transfused<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total volume of perioperative blood loss |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volumes of intraoperative and postoperative blood loss |  |  | 
| Volume of blood transfused during the perioperative period |  |  | 
| Vital signs |  |  | 
| Adverse events |  |  |