Assessment of Collaborative Requesting

ISRCTN	ISRCTN01169903
DOI	https://doi.org/10.1186/ISRCTN01169903
Protocol serial number	Protocol v5.2
Sponsor	Oxford Radcliffe Hospitals NHS Trust (UK)
Funder	UK Transplant

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ACRE
Study objectives	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.
Ethics approval(s)	Approved by Oxfordshire Research Ethics Committee A (Ref: 06/Q1604/119)
Health condition(s) or problem(s) studied	Relatives of brain stem dead patients; Organ donation - collaborative requesting
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	Proportion of relatives refusing consent for organ donation.
Key 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)
Completion date	01/08/2009

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	946
Key inclusion criteria	Relatives of patients in whom death has been determined using brain stem death criteria
Key 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
Date of first enrolment	01/04/2007
Date of final enrolment	01/08/2009

c/o Miss Sarah Edwards

Oxford
OX3 9DU
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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