ISRCTN ISRCTN01169903
DOI https://doi.org/10.1186/ISRCTN01169903
Secondary identifying numbers Protocol v5.2
Submission date
22/03/2007
Registration date
16/07/2007
Last edited
12/10/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Duncan Young
Scientific

c/o Miss Sarah Edwards
Kadoorie Centre for Critical Care Research and Education
Level 3 John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeOther
Scientific title
Study acronymACRE
Study objectivesRelatives 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.
Ethics approval(s)Approved by Oxfordshire Research Ethics Committee A (Ref: 06/Q1604/119)
Health condition(s) or problem(s) studiedRelatives of brain stem dead patients; Organ donation - collaborative requesting
InterventionThe 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.
Intervention typeOther
Primary outcome measureProportion of relatives refusing consent for organ donation.
Secondary outcome measures1. 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)
Overall study start date01/04/2007
Completion date01/08/2009

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants946
Key inclusion criteriaRelatives of patients in whom death has been determined using brain stem death criteria
Key exclusion criteria1. Relatives who do not understand written or verbal infromation for whom an interpreter is not available
2. Relatives who decline discussion on organ donation
Date of first enrolment01/04/2007
Date of final enrolment01/08/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

c/o Miss Sarah Edwards
Oxford
OX3 9DU
United Kingdom

Sponsor information

Oxford Radcliffe Hospitals NHS Trust (UK)
Hospital/treatment centre

Research and Develpment Office
Manor House
John Radcliffe Hospital
Oxford
OX3 9DU
England
United Kingdom

ROR logo "ROR" https://ror.org/03h2bh287

Funders

Funder type

Government

UK Transplant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 08/10/2009 Yes No