- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03846089
Retrograde Reperfusion Versus Antegrade Liver Transplant Reperfusion
April 4, 2022 updated by: Vivian McAlister, London Health Sciences Centre
A Propensity Score Matched Pair Analysis of Retrograde Reperfusion Versus Antegrade Liver Transplant Reperfusion
A retrospective cohort analysis was performed comparing patients that had intra operative antegrade liver reperfusions versus patients that had retrograde liver perfusion.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
A retrospective cohort analysis was performed comparing patients that had intra operative antegrade liver reperfusions versus patients that had retrograde liver perfusion.
Antegrade Reperfusion(ATR) group: after completing the caval replacement or piggy-back, for IVC anastomosis, Portal vein (PV) anastomosis was done with a running suture as normal fashion, then it was followed by the removal the clamps, starting by the supra hepatic VC, followed by the PV clamp and finally the infrahepatic VC.
It was followed by arterial anastomosis and the biliary anastomosis (duct-to-duct if possible).
Retrograde group (RETR): after completing the piggyback the IVC was declamped immediately and retrograde low pressure reperfusion of the graft with low oxygenated venous blood was established.
Central venous pressure was intended to be higher than in 8 mmHg to enable appropriate retrograde reperfusion in the transplanted liver.
Significant venous backflow via portal vein appears immediately after declamping.
Venous bleeding from the liver except portal backflow was stopped immediately after declamping the venous anastomosis, as appropriate.
Portal vein anastomosis was performed using running suture.
It was followed by arterial anastomosis and the biliary anastomosis (duct-to-duct if possible).
The endpoints are patient survival and graft survival at 1, 3,5, 10 years post liver transplantation in both groups.
To adjust for a selection bias, we will perform a propensity score analysis.
Study Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients who have undergone transplantation of the liver at LHSC.
Description
Inclusion Criteria:
- all liver transplantations between 1 Jan 2002 and 31 Dec 2005
Exclusion Criteria:
- liver retransplantation
- multiorgan transplantation
- ABO incompatible transplantation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Retrograde reperfusion
After completion of the inferior vena cava anastomosis, the clamps were removed to allow retrograde reperfusion of the graft.
|
antegrade (forward) or retrograde (backward) blood reperfusion of the liver graft
|
Antegrade reperfusion
After completion of the inferior vena cava anastomosis, the portal vein anastomosis is completed and then the clamps were removed to allow antegrade reperfusion of the graft.
|
antegrade (forward) or retrograde (backward) blood reperfusion of the liver graft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Graft survival
Time Frame: From date of transplantation until the date of next transplantation or date of death from any cause, whichever came first, assessed up to 300 months
|
Average length of time the liver graft remains in a living recipient regardless of function
|
From date of transplantation until the date of next transplantation or date of death from any cause, whichever came first, assessed up to 300 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient survival
Time Frame: From date of transplantation until the date of death from any cause assessed up to 300 months
|
Average length of time a recipient is alive regardless of presence of the second liver
|
From date of transplantation until the date of death from any cause assessed up to 300 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2002
Primary Completion (Actual)
December 31, 2005
Study Completion (Anticipated)
February 28, 2020
Study Registration Dates
First Submitted
February 16, 2019
First Submitted That Met QC Criteria
February 16, 2019
First Posted (Actual)
February 19, 2019
Study Record Updates
Last Update Posted (Actual)
April 6, 2022
Last Update Submitted That Met QC Criteria
April 4, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 106793
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Study mechanisms and de-identified subject level data will be shared with researchers who contact the principal investigator.
IPD Sharing Time Frame
From the time of publication for 5 years
IPD Sharing Access Criteria
By contacting the PI and with permission of the REB
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Transplant Failure
-
Memorial Bahçelievler HospitalCompletedLiver Diseases | Liver Failure | Liver Cirrhosis | Liver Transplant; Complications | Liver Transplant Rejection | Organ Transplant Failure or Rejection | Liver Transplant FailureTurkey
-
Methodist Health SystemRecruitingLiver Transplant FailureUnited States
-
University Health Network, TorontoActive, not recruitingLiver Transplant FailureCanada
-
Fondazione Policlinico Universitario Agostino Gemelli...Azienda Ospedaliera Città della Salute e della Scienza di Torino; IRCCS Azienda... and other collaboratorsCompletedLiver Transplant FailureItaly
-
Shanghai General Hospital, Shanghai Jiao Tong University...Unknown
-
St. Louis UniversityMid-America TransplantActive, not recruitingLiver Transplant Rejection | Liver Transplant Failure and RejectionUnited States
-
University of Wisconsin, MadisonRecruitingLiver Transplant Failure and RejectionUnited States
-
University Hospital, GhentUniversitaire Ziekenhuizen KU Leuven; University Hospital, Antwerp; Cliniques... and other collaboratorsRecruitingLiver Transplant Failure | Prognostic BiomarkersBelgium
-
Oslo University HospitalSouth-Eastern Norway Regional Health AuthorityNot yet recruitingLiver Metastases | Liver Transplant; Complications | Liver Cancer | Transplant | Transplant; Failure, Liver | Transplant; Complication, Rejection | Transplant Dysfunction
-
University Hospital, GenevaRecruitingTransplant; Failure, Liver | Impaired Oxygen DeliverySwitzerland
Clinical Trials on Graft reperfusion
-
West Kazakhstan Medical UniversityRecruitingKidney Transplantation | Ischemic Reperfusion Injury | ReperfusionKazakhstan
-
Republican Scientific and Practical Center for...UnknownLiver Transplantation | Delayed Graft Function | ReperfusionBelarus
-
Nanjing First Hospital, Nanjing Medical UniversityCompleted
-
University Hospital Inselspital, BerneCHU de Reims; University of Toronto; University of Lausanne Hospitals; Medtronic; University Hospital, Toulouse and other collaboratorsCompleted
-
The Second Affiliated Hospital of Chongqing Medical...Second Affiliated Hospital of Third Military Medical UniversityNot yet recruiting
-
University of CalgaryCompleted
-
Radboud University Medical CenterCompletedPrimary HyperaldosteronismNetherlands
-
Route 92 Medical, Inc.Active, not recruitingAcute Ischemic StrokeUnited States, New Zealand
-
Universidade Cidade de Sao PauloUniversidade Federal de Sao CarlosCompleted
-
University Hospital OstravaRecruiting