Optimising portal haemodynamics and liver parenchymal perfusion during orthotopic liver transplantation (OTL) using an implantable pump

ISRCTN	ISRCTN60164482
DOI	https://doi.org/10.1186/ISRCTN60164482
Protocol serial number	N0256107980
Sponsor	Department of Health
Funder	The Royal Free Hampstead NHS Trust (UK)

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 15/02/2018

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Brian R Davidson
Scientific

University Department of Liver Medicine and Transplantation
Royal Free Hampstead NHS Trust
Pond Street
Hampstead
London
NW3 2QG
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Optimising portal haemodynamics and liver parenchymal perfusion during orthotopic liver transplantation (OTL) using an implantable pump
Study objectives	Whether hepatic tissue oxygenation and perfusion of hepatic microcirculation can be improved with a short term mechanical augmentation of portal flow.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Liver transplantation
Intervention	Randomised controlled trial
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Service outcomes development
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/09/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	12
Key inclusion criteria	12 patients (6 patients with portal pump and 6 controls)
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	15/01/2003
Date of final enrolment	30/09/2003

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Royal Free Hampstead NHS Trust

London
NW3 2QG
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

15/02/2018: The PI of this study has informed ISRCTN that this study was never carried out.
13/02/2018: No publications found in PubMed, verifying study status with principal investigator.
07/12/2015: no publications found on PubMed.