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Trial record 9 of 883 for:    Liver Transplant

Retrograde Reperfusion Versus Antegrade Liver Transplant Reperfusion

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ClinicalTrials.gov Identifier: NCT03846089
Recruitment Status : Active, not recruiting
First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Vivian McAlister, London Health Sciences Centre

Brief Summary:
A retrospective cohort analysis was performed comparing patients that had intra operative antegrade liver reperfusions versus patients that had retrograde liver perfusion.

Condition or disease Intervention/treatment
Liver Transplant Failure Procedure: Graft reperfusion

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.

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Study Type : Observational
Actual Enrollment : 175 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: A Propensity Score Matched Pair Analysis of Retrograde Reperfusion Versus Antegrade Liver Transplant Reperfusion
Actual Study Start Date : January 1, 2002
Actual Primary Completion Date : December 31, 2005
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


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.
Procedure: Graft reperfusion
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.
Procedure: Graft reperfusion
antegrade (forward) or retrograde (backward) blood reperfusion of the liver graft




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who have undergone transplantation of the liver at LHSC.
Criteria

Inclusion Criteria:

  • all liver transplantations between 1 Jan 2002 and 31 Dec 2005

Exclusion Criteria:

  • liver retransplantation
  • multiorgan transplantation
  • ABO incompatible transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846089


Sponsors and Collaborators
London Health Sciences Centre
Investigators
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Principal Investigator: Vivian McAlister London Health Sciences Center

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Responsible Party: Vivian McAlister, Professor of Surgery, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03846089     History of Changes
Other Study ID Numbers: 106793
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study mechanisms and de-identified subject level data will be shared with researchers who contact the principal investigator.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: From the time of publication for 5 years
Access Criteria: By contacting the PI and with permission of the REB

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No