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 |
| Secondary identifying numbers | N0236106542 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Grounds
Scientific
Scientific
Adult Intensive Care Unit
St James Wing
St George's Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Study information
| Study design | Single centre randomised double-blind parallel group placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/06/2002 |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Adult Intensive Care Unit
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
St George's Healthcare NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
