Use of recombinant activated Factor Seven in bleeding extracorporeal membrane oxygenation patients post cardiac surgery: a randomised prospective study
| ISRCTN | ISRCTN98382551 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98382551 |
| Secondary identifying numbers | N0012154243 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 01/05/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr C Ng
Scientific
Scientific
PICU
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Use of recombinant activated Factor Seven in bleeding extracorporeal membrane oxygenation patients post cardiac surgery: a randomised prospective study |
| Study objectives | Will an early use of Factor Seven (FVII): 1. Stop bleeding? 2. Reduce use of other blood products? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Extracorporeal membrane oxygenation (ECMO) patients post cardiac surgery |
| Intervention | 1. Use of FVII 2. Placebo |
| Intervention type | Other |
| Primary outcome measure | 1. Amount of post-operative bleeding 2. Use of human blood products |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2004 |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | Post cardiac surgery patients |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2004 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Great Ormond Street Hospital
London
WC1N 3JH
United Kingdom
WC1N 3JH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (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 |
