St George's Hospital UK Study of the use of recombinant factor VIIa in pelvic fracture and acetabular reconstruction
| ISRCTN | ISRCTN02543733 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02543733 |
| Protocol serial number | N0236106542 |
| Sponsor | Department of Health (UK) |
| Funder | St George's Healthcare NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 10/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Adult Intensive Care Unit
St James Wing
St George's Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised double-blind parallel group placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Acetabular reconstruction |
| Intervention | Use of recombinant factor VIIa in pelvic fracture and acetabular reconstruction |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Recombinant factor VIIa (rFVIIa) |
| Primary outcome measure(s) |
Total volume of perioperative blood loss |
| Key secondary outcome measure(s) |
1. perioperative transfusion requirement (total volume of allogeneic blood components and salvaged RBC, total number of units of allogeneic blood components) |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 48 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 31/03/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
SW17 0QT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2005 | Yes | No |
