| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN01169903 |
| Date ISRCTN assigned | 16/07/2007 |
| Local reference number(s) | Protocol v5.2 |
| Public title | Assessment of Collaborative Requesting |
| Scientific title |
|
| Acronym | ACRE |
| Disease/condition/study domain | Relatives of brain stem dead patients; Organ donation - collaborative requesting |
| Study hypothesis | Relatives of patients in whom death has been determined using brain stem death criteria are more likely to consent to organ donation when interviewed by the clinical team if a donor transplant co-ordinator is present, compared with relatives interviewed by the clinical team alone. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Approved by Oxfordshire Research Ethics Committee A (Ref: 06/Q1604/119) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Relatives of patients in whom death has been determined using brain stem death criteria |
| Participants - exclusion criteria | 1. Relatives who do not understand written or verbal infromation for whom an interpreter is not available
2. Relatives who decline discussion on organ donation |
| Patient information material |
|
| Anticipated start date | 01/04/2007 |
| Anticipated end date | 01/08/2009 |
| Status of trial | Ongoing |
| Target number of participants | 946 |
| Interventions | The intervention is collaborative requesting which is the addition of a donor transplant co-ordinator to the team requesting organ donation. The routine arm is the relatives interviewed by the clinical team alone. |
| Primary outcome measure(s) | Proportion of relatives refusing consent for organ donation. |
| Secondary outcome measure(s) | 1. Number of patients in whom the family consent to beating heart organ donation
2. Solid organs retrieved by type
3. Solid organs transplanted by type
4. Tissues retrieved by type
5. Consent rates by predefined subgroup (relative relationship to donor; ethnic group and sex of donor and next of kin; clinician seniority and sex; sex of donor transplant co-ordinator) |
| Sources of funding | UK Transplant |
| Sponsor name | Oxford Radcliffe Hospitals NHS Trust (UK) |
| Sponsor details | Research and Develpment Office
Manor House
John Radcliffe Hospital
Oxford
United Kingdom
OX3 9DU |
| Contact name | Dr Duncan Young |
| Contact details | c/o Miss Sarah Edwards
Kadoorie Centre for Critical Care Research and Education
Level 3 John Radcliffe Hospital
Oxford
United Kingdom
OX3 9DU |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN01169903 |
| Date last extracted from ISRCTN register | 17/04/2008 |
