Statins for improving organ outcome in transplantation

ISRCTN	ISRCTN11440354
DOI	https://doi.org/10.1186/ISRCTN11440354
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	288722
Protocol serial number	CPMS 49404, IRAS 288722
Sponsor	Newcastle upon Tyne Hospitals NHS Foundation Trust
Funder	NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR131124

Submission date: 09/07/2021
Registration date: 03/08/2021
Last edited: 11/11/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
All organs removed from donors have already suffered a degree of damage. As the brain dies (and all of these donors are brain-stem dead) chemicals are released which cause an “inflammation” of the whole body. Measurements of this “inflammation” link to how well the organs function in the recipient after transplant.
Statins are cholesterol-lowering drugs that have benefits across a range of health problems. In particular, statins damp down inflammation in the body and in individual organs. Statins protect the lungs and kidneys in a range of illnesses.
Recently, transplant doctors in Finland linked all this information in an innovative clinical study. Organ donors who were about to donate their heart were randomly allocated to receive a dose of a statin. After the transplant, the recipients who received a heart from a donor who had statins had less heart damage. The numbers were modest, and no survival advantage could be demonstrated. There was a small benefit for lung and liver recipients, but importantly there was no disadvantage in receiving any organ from a donor who had received the drug.
A significant number of hearts and other organs offered for transplant by the donor family are not used; for the heart, this figure is about 75%. The reason for being so selective is that poor function of the donor heart in the recipient is by far the most common cause of death after a transplant. Any step in the donor which might improve the transplanted heart could have a major benefit to the recipient. The same principle applies to all the other organs transplanted.
The aim of this study is to investigate whether giving deceased organ donors a single dose of the drug simvastatin, a very commonly used and safe drug, is beneficial for transplant recipients.

Who can participate?
Adult brain dead organ donors across the UK per year over 4 years

What does the study involve?
Half the donors will receive the drug (in addition to their standard donor care), compared to the other half of donors who will receive standard care only. The drug is given through a tube running into the stomach, already present in 80% of donors, but required to be placed in the other 20%. The drug will be given as soon as the donor family have consented to both organ donation and involvement of their loved one in research.
Half of all the transplant recipients will receive an organ from a donor given the drug. The researchers will follow the results of transplant, focussing on the heart recipients, but for all those receiving these organs, comparing what happens in those who received the drug-treated organs, and those who did not. This is done with data already collected in the national transplant database. No extra data or blood samples will be needed from recipients.

What are the possible benefits and risks of participating?
Unfortunately, there will be no benefit to the donors but there may be a benefit to the person receiving their organs if they are transplanted. People receiving an organ that has been treated with simvastatin may have better outcomes, and it is hoped that this will mean more organs can be transplanted successfully, but it is not known whether this will be the case. Simvastatin is a licensed drug and one of the most prescribed drugs in the UK. There are some risks associated with taking statins for a long time, but this will be a single dose so these risks are not considered a problem at all for this study. With any drug there is a risk of an allergic reaction. This is expected to be very rare as there has only been one case of this reported.

Where is the study run from?
NHS Blood and Transplant Clinical Trials Unit (UK)

When is the study starting and how long is it expected to run for?
October 2020 to June 2026

Who is funding the study?
National Institute of Health Research (NIHR) (UK)

Who is the main contact?
Ashley Foster, SIGNET@nhsbt.nhs.uk

Contact information

None Ashley Foster
Scientific

NHS Blood and Transplant Clinical Trials Unit
Long Road
Cambridge
CB2 0PT
United Kingdom

Phone	+44 (0)1223 588 016
Email	SIGNET@nhsbt.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomized; Interventional; Design type: Process of Care, Drug, Other
Secondary study design	Randomised controlled trial
Participant information sheet	ISRCTN11440354_PIS_donor relative_v11_11Jun2021.pdf
Scientific title	Statins in organ donor management: an evaluation of the benefits of a single dose of simvastatin given to potential organ donors declared dead by neurological criteria on outcomes in organ recipients
Study acronym	SIGNET
Study objectives	Does treatment of potential organ donors with simvastatin during protocolised care after diagnosis of death using neurological criteria improve outcomes in patients undergoing transplantation?
Ethics approval(s)	Approved 28/06/2021, London - Queen Square Research Ethics Committee (HRA NRES Centre Bristol, 3rd Floor, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8061; queensquare.rec@hra.nhs.uk), REC ref: 21/LO/0412
Health condition(s) or problem(s) studied	Organ transplantation
Intervention	This is a multi-centre, single-blind prospective, group sequential, randomised controlled trial. Randomisation will be in a 1:1 ratio and will be stratified according to whether the donor was receiving statin therapy at ICU admission. Setting ICUs within Level 1 or 2 donating hospitals: defined as a mean number of donors per year > 6 by NHS Blood and Transplant. Screening Adult organ donors will be identified by the Specialist Nurses in Organ Donation (SNODs). After they have been through the organ donation consent process with the donor family, they will go through the study-specific consent. The SNODs will complete an eligibility checklist which will be countersigned by the prescribing ICU doctor if the patient is randomised to receive the intervention. No screening logs will be completed. Randomisation Following study-specific consent, participants will be randomised using an online randomisation service, called SealedEnvelope, and given a unique Randomisation Number. The treatment allocation will also be provided. Treatment The study treatment is 80 mg simvastatin in addition to protocolised standard care. This will be compared to protocolised standard care alone. If randomised to receive the intervention, this will be prescribed by an ICU doctor and issued from hospital stock. The tablet will be crushed, mixed with 20 ml sterile water (hospital stock) and administered via nasogastric tube. Nasogastric tubes are already in place for 80% of organ donors but if this is not already in place, this will be required. Follow up Although there will be some intervention and donor data collected by the research team onto an eCRF, most of the data from the donors, and all recipient data, is already collected as part of standard care on the UK Transplant Registry. No additional information or samples will be needed from recipients. Safety reporting Serious adverse events will be reported to the REC within 15 days of the clinical team becoming aware. Due to the low-risk intervention and complex patient population, serious adverse events that need reporting will be those assessed by the PI as being related to the study and unexpected. The researchers will also record events that progress to the loss of capacity to donate as a result of the study procedure.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Simvastatin
Primary outcome measure(s)	Updated primary outcome measure as of 01/05/2024: The primary outcome measure is a composite outcome of death, cardiac mechanical circulatory support or renal replacement therapy within the first 30 days post heart transplant Previous primary outcome measure: Composite of death, cardiac mechanical circulatory support or renal replacement therapy, determined by the recipient status on the UK Transplant Registry (UKTR) at 30 days
Key secondary outcome measure(s)	1. Organ utilisation rate, measured by the proportion of organs offered that were transplanted for each organ separately and based on the records held by the UK Transplant Registry (UKTR) during the 60-month trial duration, records completed at 30-days or at initial discharge post-transplant whichever is sooner 2. Graft survival for all transplanted organs, based on the records held by the UKTR, at 30 days, 3 months and 12 months 3. Patient survival, determined by status on the UKTR, at 30 days, 3 months and 12 months 4. Length of ITU stay, measured by the number of days the patient was on ITU, based on the records held by the UKTR from the point of transplant to discharge from ITU at discharge from transplant admission 5. Length of hospital stay, measured by the number of days the patient was in hospital, based on the records held by the UKTR excluding kidney recipients at from the point of transplant to discharge from hospital at discharge from transplant admission 6. Proportion of heart recipients requiring mechanical circulatory support up to 30 days, based on the records held by the UKTR 7. Proportion of cardiac recipients requiring renal replacement therapy up to 30 days, based on the records held by the UKTR 8. Patient survival for heart recipients, measured by their status on the UKTR, at 30 days 9. Number of treated rejection episodes for each organ, based on records held by the UKTR, at 3 and 12 months 10. Estimated glomerular filtration rate for kidney recipients, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (2009) from data held by the UKTR at 12 months 11. Proportion of kidney recipients with delayed graft function, defined as the need for dialysis in the first 7 days, based on records held by the UKTR 12. Number of days liver recipients spent ventilated, based on records held by the UKTR at 30 days or at initial discharge post-transplant whichever is sooner 13. Proportion of liver recipients with individual post-operative complications, measured by indicators recording the presence or absence of hepatic artery thrombosis, portal vein thrombosis, inferior vena cava (IVC)/hepatic vein occlusion, haemorrhage requiring reoperation, biliary tract leaks, biliary tract stricture requiring intervention as recorded by the UKTR at 30-days or at initial discharge post-transplant whichever is sooner 14. For liver recipients, the levels of serum creatinine (μmol/), bilirubin (μmol/) and alkaline phosphatase (IU/L) at 12 months, based on the UKTR records 15. FEV1 in lung recipients based on records held in the UKTR and measured in both absolute terms in litres, from the two best recent measurements as well as % predicted1 as measured at 12 months 16. Proportion of pancreas recipients (including simultaneous pancreas-kidney recipients) with initial pancreas graft function, based on records held on the UKTR at 30-days or at initial discharge post-transplant whichever is sooner 17. Number of treated pancreas rejection episodes in pancreas and simultaneous pancreas-kidney recipients at 3 and 12 months based on the UKTR 18. Categorised causes of graft loss in pancreas and simultaneous pancreas-kidney recipients as recorded on the UKTR at 12 months (causes recorded for pancreas graft failure include: vascular thrombosis, infection, bleeding, anastomotic leak, pancreatitis, primary non-function, hyperacute, acute and chronic rejection, preservation/procurement problem, death with functioning graft, patient declined medication) 19. Proportion of pancreas and simultaneous pancreas-kidney recipients with pancreatitis as recorded in the UKTR up to 3 months 20. C-peptide in pancreas islet recipients, measured by meal tolerance test in units of pmol/l, at 3-month follow-up in the UKTR
Completion date	30/06/2026

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	2600
Total final enrolment	1694
Key inclusion criteria	1. Within a recruiting Intensive Care Unit 2. Patients diagnosed dead using neurological criteria 3. Consent for organ donation in place, as defined by the Human Tissue Act and accompanying legislation and Codes of Practice 4. Study-specific consent from the donor family
Key exclusion criteria	1. Aged <18 years 2. Planned donation after cessation of circulation (DCD) 3. Known donor allergic hypersensitivity to simvastatin
Date of first enrolment	14/09/2021
Date of final enrolment	13/09/2025

Locations

Countries of recruitment

United Kingdom
England
Northern Ireland
Scotland
Wales

Study participating centres

Aberdeen Royal Infirmary

Foresterhill Health Campus
Foresterhill Rd
Aberdeen
AB25 2ZN
Scotland

Royal Gwent Hospital

Cardiff Rd
Newport
NP20 2UB
Wales

Monklands District General Hospital

Monkscourt Ave
Airdrie
ML6 0JS
Scotland

Hairmyres Hospital

218 Eaglesham Rd
East Kilbride
Glasgow
G75 8RG
Scotland

Wishaw General Hospital

50 Netherton St
Wishaw
ML2 0DP
Scotland

William Harvey Hospital

Kennington Rd
Willesborough
Ashford
TN24 0LZ
England

Kent and Canterbury Hospital

Ethelbert Rd
Canterbury
CT1 3NG
England

Queen Elizabeth the Queen Mother Hospital

Ramsgate Rd
Margate
CT9 4AN
England

University Hospital Ayr

Dalmellington Rd
Ayr
KA6 6DX
Scotland

University Hospital Crosshouse

Kilmarnock Rd
Crosshouse
Kilmarnock
KA2 0BE
Scotland

John Radcliffe Hospital

Headley Way
Headington
Oxford
OX3 9DU
England

Ysbyty Gwynedd

Penrhosgarnedd
Bangor
LL57 2PW
Wales

Glan Clwyd Hospital

Rhuddlan Rd
Bodelwyddan
Rhyl
LL18 5UJ
Wales

Wrexham Maelor Hospital

Croesnewydd Rd
Wrexham
LL13 7TD
Wales

Barnet Hospital

Wellhouse Ln
Barnet
EN5 3DJ
England

Royal Free Hospital

Pond St
London
NW3 2QG
England

Royal United Hospital

Combe Park
Bath
BA1 3NG
England

Belfast City Hospital

Lisburn Rd
Belfast
BT9 7AB
Northern Ireland

Mater Infirmorum Hospital

45-51 Crumlin Rd
Belfast
BT14 6AB
Northern Ireland

Royal Victoria Hospital

274 Grosvenor Rd
Belfast
BT12 6BA
Northern Ireland

Queen Elizabeth Hospital Birmingham

Mindelsohn Way
Birmingham
B15 2TH
England

Birmingham City Hospital

Dudley Rd
Birmingham
B18 7QH
England

Sandwell District General Hospital

Lyndon
West Bromwich
B71 4HJ
England

Royal Blackburn Hospital

Haslingden Rd
Blackburn
BB2 3HH
England

Blackpool Victoria Hospital

Whinney Heys Rd
Blackpool
FY3 8NR
England

Royal Bolton Hospital

Minerva Rd
Farnworth
Bolton
BL4 0JR
England

Pilgrim Hospital

Sibsey Rd
Boston
PE21 9QS
England

Lincoln County Hospital

Greetwell Rd
Lincoln
LN2 5QY
England

Royal Bournemouth Hospital

Castle Ln E
Bournemouth
BH7 7DW
England

Princess of Wales Hospital

Coity Rd
Bridgend
CF31 1RQ
Wales

Prince Charles Hospital

Gurnos Rd
Merthyr Tydfil
CF47 9DT
Wales

Royal Glamorgan Hospital

Ynysmaerdy
Pontyclun
CF72 8XR
Wales

Royal Sussex County Hospital

Barry Building
Eastern Rd
Brighton
BN2 5BE
England

Princess Royal Hospital

Lewes Rd
Haywards Heath
RH16 4EX
England

Bristol Royal Infirmary

Upper Maudlin St
Bristol
BS2 8HW
England

Southmead Hospital

Southmead Rd
Bristol
BS10 5NB
England

Royal Derby Hospital

Uttoxeter Rd
Derby
DE22 3NE
England

Fairfield General Hospital

Rochdale Old Rd
Bury
BL9 7TD
England

Royal Oldham Hospital

Rochdale Rd
Oldham
OL1 2JH
England

Frimley Park Hospital

Portsmouth Rd
Frimley
Camberley
GU16 7UJ
England

Wexham Park Hospital

Wexham St
Slough
SL2 4HL
England

Addenbrooke's Hospital

Hills Rd
Cambridge
CB2 0QQ
England

University Hospital of Wales,

Heath Park Way
Cardiff
CF14 4XW
Wales

St Peter's Hospital

Guildford St
Lyne
Chertsey
KT16 0PZ
England

Countess of Chester Hospital

Liverpool Rd
Chester
CH2 1UL
England

St Richard's Hospital

Spitalfield Ln
Chichester
PO19 6SE
England

Worthing Hospital

Lyndhurst Rd
Worthing
BN11 2DH
England

Royal Preston Hospital

Sharoe Green Ln
Fulwood
Preston
PR2 9HT
England

Colchester Hospital

Turner Rd
Colchester
CO4 5JL
England

Ipswich Hospital

Heath Rd
Ipswich
IP4 5PD
England

Hull Royal Infirmary

Anlaby Rd
Hull
HU3 2JZ
England

University Hospital Coventry & Warwickshire

Clifford Bridge Rd
Coventry
CV2 2DX
England

Darlington Memorial Hospital

Hollyhurst Rd
Darlington
DL3 6HX
England

University Hospital of North Durham

North Rd
Durham
DH1 5TW
England

Ninewells Hospital

James Arrott Dr
Dundee
DD2 1SG
Scotland

Eastbourne District General Hospital

Kings Dr
Eastbourne
BN21 2UD
England

Conquest Hospital

The Ridge
Saint Leonards-on-Sea
TN37 7RD
England

Royal Infirmary of Edinburgh

51 Little France Cres
Old Dalkeith Rd
Edinburgh
EH16 4SA
Scotland

Western General Hospital

Crewe Rd S
Edinburgh
EH4 2XU
Scotland

St John's Hospital

Livingston
Howden W Rd
Howden
Livingston
EH54 6PP
Scotland

South West Acute Hospital

124 Irvinestown Rd
Enniskillen
BT74 6DN
Northern Ireland

Altnagelvin Area Hospital

Glenshane Rd
Londonderry
BT47 6SB
Northern Ireland

Medway Maritime Hospital

Windmill Road
Gillingham
ME7 5NY
England

Glasgow Royal Infirmary

84 Castle St
Glasgow
G4 0SF
Scotland

Queen Elizabeth University Hospital

1345 Govan Rd
Glasgow
G51 4TF
Scotland

Royal Alexandra Hospital

Castlehead
Paisley
PA2 9PJ
Scotland

Diana Princess of Wales Hospital

Scartho Rd
Grimsby
DN33 2BA
England

Scunthorpe General Hospital

Cliff Gardens
Scunthorpe
DN15 7BH
England

Calderdale Royal Hospital

-
Halifax
HX3 0PW
England

Huddersfield Royal Infirmary

Acre St
Lindley
Huddersfield
HD3 3EA
England

Harefield Hospital

Hill End Rd
Harefield
Uxbridge
UB9 6JH
England

Royal Brompton Hospital,

Sydney St
London
SW3 6NP
England

Northwick Park Hospital

Watford Rd
Harrow
HA1 3UJ
England

Ealing Hospital

601 Uxbridge Rd
Southall
UB1 3HW
England

King George Hospital

Barley Ln
Ilford
IG3 8YB
England

Queen's Hospital

Rom Valley Way
Romford
RM7 0AG
England

Ipswich Hospital

Heath Rd
Ipswich
IP4 5PD
England

Leeds General Infirmary

Great George St
Leeds
LS1 3EX
England

St James's University Hospital

Beckett St
Harehills
Leeds
LS9 7TF
England

Glenfield Hospital

Groby Rd
Leicester
LE3 9QP
England

Leicester Royal Infirmary

Infirmary Square
Leicester
LE1 5WW
England

Royal Liverpool University Hospital

Prescot St
Liverpool
L7 8XP
England

Aintree University Hospital

Lower Ln
Liverpool
L9 7AL
England

The Walton Centre

Lower Ln
Liverpool
L9 7LJ
England

Charing Cross Hospital

Fulham Palace Rd
London
W6 8RF
England

Hammersmith Hospital

72 Du Cane Rd
London
W12 0HS
England

St Mary's Hospital

Praed St
London
W2 1NY
England

King's College Hospital

Denmark Hill
London
SE5 9RS
England

Princess Royal University Hospital

Farnborough Common
Orpington
BR6 8ND
England

National Hospital for Neurology and Neurosurgery

Queen Square
London
WC1N 3BG
England

University College Hospital

235 Euston Rd
London
NW1 2BU
England

Newham University Hospital

Glen Rd
London
E13 8SL
England

St Bartholomew's Hospital

W Smithfield
London
EC1A 7BE
England

The Royal London Hospital

Whitechapel Rd
London
E1 1FR
England

Whipps Cross Hospital

Whipps Cross Road
London
E11 1NR
England

St George's Hospital

Blackshaw Rd
London
SW17 0QT
England

St Thomas' Hospital

Westminster Bridge Rd
London
SE1 7EH
England

Queen Elizabeth Hospital

Stadium Rd
London
SE18 4QH
England

University Hospital Lewisham

Lewisham High St
London
SE13 6LH
England

Luton & Dunstable University Hospital

Lewsey Rd
Luton
LU4 0DZ
England

Manchester Royal Infirmary

Oxford Rd
Manchester
M13 9WL
England

Wythenshawe Hospital

Southmoor Rd
Wythenshawe
Manchester
M23 9LT
England

The James Cook University Hospital

Marton Rd
Middlesbrough
TS4 3BW
England

Newcastle Freeman Hospital,

Freeman Rd
High Heaton
Newcastle upon Tyne
NE7 7DN
England

Royal Victoria Infirmary

Queen Victoria Rd
Newcastle upon Tyne
NE1 4LP
England

Northumbria Specialist Emergency Care Hospital

Northumbria Way
Cramlington
NE23 6NZ
England

Norfolk & Norwich University Hospital

Colney Ln
Colney
Norwich
NR4 7UY
England

Nottingham City Hospital

Hucknall Rd
Nottingham
NG5 1PB
England

Queen's Medical Centre

Derby Rd
Lenton
Nottingham
NG7 2UH
England

Derriford Hospital

Derriford Rd
Plymouth
PL6 8DH
England

Queen Alexandra Hospital

Cosham
Portsmouth
PO6 3LY
England

Whiston Hospital,

Warrington Rd
Rainhill
Prescot
L35 5DR
England

Alexandra Hospital

Woodrow Dr
Redditch
B98 7UB
England

Worcestershire Royal Hospital

Charles Hastings Way
Worcester
WR5 1DD
England

Salford Royal Hospital

Stott Ln
Salford
M6 8HD
England

Scarborough General Hospital,

Woodlands Dr
Scarborough
YO12 6QL
England

York District Hospital,

Clifton
York
YO31 8HE
England

Northern General Hospital

Herries Rd
Sheffield
S5 7AU
England

Royal Hallamshire Hospital

Glossop Rd
Broomhall
Sheffield
S10 2JF
England

Southampton General Hospital

Tremona Rd
Southampton
SO16 6YD
England

Lister Hospital

Coreys Mill Ln
Stevenage
SG1 4AB
England

Royal Stoke University Hospital

Newcastle Rd
Stoke-on-Trent
ST4 6QG
England

Great Western Hospital

Marlborough Rd
Swindon
SN3 6BB
England

Watford General Hospital

Vicarage Rd
Watford
WD18 0HB
England

New Cross Hospital

Wolverhampton Rd
Heath Town
Wolverhampton
WV10 0QP
England

Morriston Hospital

Heol Maes Eglwys
Cwmrhydyceirw
Swansea
SA6 6NL
Wales

South Tyneside NHS Foundation Trust

South Tyneside District Hospital
Harton Lane
South Shields
NE34 0PL
England

Sunderland Royal Hospital

Kayll Road
Sunderland
SR4 7TP
England

Basildon

Basildon Hospital
Nethermayne
Basildon
SS16 5NL
England

Gloucestershire Royal Hospital

Great Western Road
Gloucester
GL1 3NN
England

Cheltenham General Hospital

Sandford Road
Cheltenham
GL53 7AN
England

Craigavon Area Hospital

Lurgan Rd
Craigavon
BT63 5QQ
Northern Ireland

Stoke Mandeville Hospital

Mandeville Road
Aylesbury
HP21 8AL
England

Wycombe General Hospital

Queen Alexandra Road
High Wycombe
HP11 2TT
England

Royal Cornwall Hospitals NHS Trust

Royal Cornwall Hospital
Treliske
Truro
TR1 3LJ
England

Pinderfields and Pontefract Hospitals NHS Trust

Rowan House
Pinderfields General Hospital
Aberford Road
Wakefield
WF1 4EE
England

North Tees and Hartlepool NHS Foundation Trust

University Hospital of Hartlepool
Holdforth Road
Hartlepool
TS24 9AH
England

Royal Berkshire Hospital

Royal Berkshire Hospital
London Road
Reading
RG1 5AN
England

Chesterfield Royal Hospital NHS Foundation Trust

Chesterfield Road
Calow
Chesterfield
S44 5BL
England

Doncaster & Bassetlaw Hospitals

Doncaster Royal Infirmary
Thorne Road
Doncaster
DN2 5LT
England

Doncaster & Bassetlaw Hospitals

Doncaster Royal Infirmary
Thorne Road
Doncaster
DN2 5LT
England

Withybush General Hospital

Fishguard Road
Haverfordwest
SA61 2PZ
Wales

West Wales General Hospital

Dolgwili Road
Carmarthen
SA31 2AF
Wales

Bronglais General Hospital

Bronglais Hospital
Caradoc Road
Aberystwyth
SY23 1ER
Wales

Cumberland Infirmary

Newtown Road
Carlisle
CA2 7HY
England

West Cumberland Hospital

Homewood
Hensingham
Whitehaven
CA28 8JG
England

Taunton

Musgrove Park Hospital
Taunton
TA1 5DA
England

Forth Valley Royal Hospital

Stirling Road
Larbert
FK5 4WR
Scotland

Maidstone

Maidstone Hospital
Hermitage Lane
Maidstone
ME16 9QQ
England

Tunbridge Wells Hospital

The Tunbridge Wells Hospital
Tonbridge Road
Pembury
Tunbridge Wells
TN2 4QJ
England

Raigmore Hospital

Old Perth Rd
Inverness
IV2 3UJ
Scotland

Royal Shrewsbury Hospital

Mytton Oak Road
Shrewsbury
SY3 8XQ
England

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Access to the final dataset for additional analyses will be permitted with the agreement of the Trial Steering Committee. Participant-level data will be held by NHS Blood and Transplant.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		18/09/2024	20/09/2024	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	For organ donor's relative version 11	11/06/2021	04/05/2023	No	Yes
Participant information sheet	For organ recipient version 10	12/04/2021	04/05/2023	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol (other)	v20	07/12/2022	04/05/2023	No	No
Protocol file	version 20	07/12/2022	04/05/2023	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN11440354_PIS_donor relative_v11_11Jun2021.pdf: For organ donor's relative
ISRCTN11440354_PIS_recipient_v10_12Apr2021.pdf: For organ recipient
ISRCTN11440354_Protocol_v20_07Dec2022.pdf: Protocol file

Editorial Notes

11/11/2025: Total final enrolment added.
07/11/2025: Contact details updated.
20/09/2024: Publication reference added.
01/05/2024: The following changes were made to the study record:
1. Primary outcome measure updated.
2. The study participating centres were updated to remove Nevill Hall Hospital, Horton General Hospital, Birmingham Heartlands Hospital, Good Hope Hospital, Queens Hospital, North Manchester General Hospital, Chorley and South Ribble Hospital, Castle Hill Hospital, Perth Royal Infirmary, Inverclyde Royal Hospital, Hinchingbrooke Hospital, Peterborough City Hospital, Northampton General Hospital, Royal Papworth Hospital and add Morriston Hospital, South Tyneside NHS Foundation Trust, Sunderland Royal Hospital, Basildon Hospital, Gloucestershire Royal Hospital, Cheltenham General Hospital, Craigavon Area Hospital, Stoke Mandeville Hospital, Wycombe General Hospital, Royal Cornwall Hospitals NHS Trust, Pinderfields and Pontefract Hospitals NHS Trust, North Tees and Hartlepool NHS Foundation Trust, Royal Berkshire Hospital, Chesterfield Royal Hospital NHS Foundation Trust, Doncaster & Bassetlaw Hospitals, Doncaster & Bassetlaw Hospitals, Withybush General Hospital, West Wales General Hospital, Bronglais General Hospital, Cumberland Infirmary, West Cumberland Hospital, Musgrove Park Hospital (taunton), Forth Valley Royal Hospital, Maidstone Hospital, Tunbridge Wells Hospital, Raigmore Hospital, Royal Shrewsbury Hospital.
04/05/2023: The following changes have been made:
1. The protocol has been linked and uploaded.
2. Two participant information sheets have been uploaded.
09/07/2021: Trial's existence confirmed by the NIHR.