| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN98382551 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0012154243 |
| Public title | Use of recombinant activated Factor Seven in bleeding extracorporeal membrane oxygenation patients post cardiac surgery: a randomised prospective study |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Extracorporeal membrane oxygenation (ECMO) patients post cardiac surgery |
| Study hypothesis | Will an early use of Factor Seven (FVII):
1. Stop bleeding?
2. Reduce use of other blood products? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Post cardiac surgery patients |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/04/2004 |
| Anticipated end date | 31/03/2006 |
| Status of trial | Completed |
| Target number of participants | 40 |
| Interventions | Randomised controlled trial. Random allocation to:
A. Use of FVII
B. Placebo |
| Primary outcome measure(s) | 1. Amount of post-operative bleeding
2. Use of human blood products |
| Secondary outcome measure(s) | Not applicable |
| Sources of funding | Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health |
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr C Ng |
| Contact details | PICU
Great Ormond Street Hospital
Great Ormond Street
London
United Kingdom
WC1N 3JH |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN98382551 |
| Date last extracted from ISRCTN register | 17/04/2008 |
