Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0236106542
Study information
Scientific title
Acronym
Study hypothesis
This study will evaluate the possible effect of recombinant factor VIIa (rFVIIa) in the treatment of severe bleeding in severely injured trauma patients undergoing major orthopaedic reconstructive surgery.
Ethics approval
Not provided at time of registration
Study design
Single centre randomised double-blind parallel group placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Surgery: Acetabular reconstruction
Intervention
Use of recombinant factor VIIa in pelvic fracture and acetabular reconstruction
Intervention type
Drug
Phase
Not Applicable
Drug names
Recombinant factor VIIa (rFVIIa)
Primary outcome measure
Total volume of perioperative blood loss
Secondary outcome measures
1. perioperative transfusion requirement (total volume of allogeneic blood components and salvaged RBC, total number of units of allogeneic blood components)
2. number of patients transfused with allogeneic blood components
3. total volume of crystalloid (Hartmann's solution, dextrose saline, normal saline) and colloid (succinylated gelatin) fluids infused
4. total operating time
5. time taken after entry to intensive care unit (ICU) or recovery unit to reach normal body temperature (36.337.1°C) and acidbase status (blood pH 7.357.45 with standard base excess 2 to +2)
6. time spent in ICU after surgery
7. days of hospitalization
8. number of times a patient was returned to the operating theatre
Overall trial start date
01/06/2002
Overall trial end date
31/03/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 1860 yr old
2. major pelvicacetabular fracture caused by trauma
3. scheduled for semi-elective large reconstruction surgery with the potential of blood loss exceeding 50% of circulating blood volume
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48
Participant exclusion criteria
1. history of thrombosis (deep vein thrombosis, pulmonary embolism, cerebral thrombosis)
2. severe head injuries or an abnormal CT scan of the head due to head injuries
3. base deficit of greater than 15 mEq litre1 or severe acidosis (pH<7.0.) before surgery
4. body weight exceeding 135 kg
5. known or suspected allergy to any drug that may be administered during the course of the study
6. cardiac arrest after trauma and before surgery at St George's Hospital
7. known congenital bleeding disorders
8. known pregnancy or positive pregnancy test at enrolment
9. previous participation in this study
10. previous receipt of rFVIIa within 48 h of screening
11. currently participating or having participated in another investigational drug study within the last 30 days
Recruitment start date
01/06/2002
Recruitment end date
31/03/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Adult Intensive Care Unit
London
SW17 0QT
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
St George's Healthcare NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15734783
Publication citations
-
Results
Raobaikady R, Redman J, Ball JA, Maloney G, Grounds RM, Use of activated recombinant coagulation factor VII in patients undergoing reconstruction surgery for traumatic fracture of pelvis or pelvis and acetabulum: a double-blind, randomized, placebo-controlled trial., Br J Anaesth, 2005, 94, 5, 586-591, doi: 10.1093/bja/aei102.