Effect of Discarding Initial Reperfusion Blood on Hemodynamics, Liver Function, and 30-Day Outcomes in Liver Transplantation

NCT07631689 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-06-08

No results posted yet for this study

Summary

Hepatic reperfusion during liver transplantation remains a critical phase associated with significant hemodynamic and systemic disturbances, despite advances in surgical and anesthetic management. This phase is characterized by the release of acidotic, hypothermic, and hyperkalemic blood containing metabolic byproducts and inflammatory mediators resulting from ischemia-reperfusion injury.

Clinically, reperfusion is associated with hemodynamic instability, including reductions in cardiac output and arterial pressure, as well as cardiac dysfunction and arrhythmias, often requiring pharmacologic support. These alterations may affect not only immediate intraoperative stability but also short- and long-term outcomes for both the patient and the graft.

The abrupt restoration of blood flow to the transplanted liver leads to the systemic release of accumulated metabolites, reactive oxygen species, and inflammatory mediators, contributing to a systemic inflammatory response that may impact distant organs, including the kidneys and heart.

Several revascularization strategies have been investigated to mitigate reperfusion-related injury: initial reperfusion via the portal vein, initial reperfusion through the hepatic artery, and simultaneous reperfusion through the portal vein and hepatic artery.

A less frequently used and insufficiently studied strategy, not routinely or systematically implemented, involves diverting the initial reperfusion blood from the graft to the surgical field, followed by the restoration of hepatic blood outflow to the systemic circulation.

This study hypothesizes that discarding the initial reperfusion blood via the infrahepatic vena cava will attenuate early hemodynamic, metabolic, and inflammatory changes and reduce postoperative complications compared to conventional reperfusion techniques.

Conditions

  • Liver Transplantation
  • Ischaemia Reperfusion Injury
  • Perioperative Complications

Interventions

PROCEDURE

Reperfusion Blood Discard

Discarding of the initial 180 mL of reperfusion blood from the graft via the infrahepatic vena cava during liver transplantation prior to restoration of hepatic venous outflow to systemic circulation.

PROCEDURE

Standard Liver Transplantation

Conventional liver transplantation without discarding the initial reperfusion blood.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Joel Avancini Rocha Filho, MD, PhD · Hospital das Clínicas, University of São Paulo Medical School

  • Estela Regina Ramos Figueira, MD, PhD · Hospital das Clínicas, University of São Paulo Medical School

  • Maria Jose Carvalho Carmona, MD, PhD · Hospital das Clínicas, University of São Paulo Medical School

  • Wellington Andraus, MD, PhD · Hospital das Clínicas, University of São Paulo Medical School

  • Rui Carlos Detsch Junior, MD · Hospital das Clínicas, University of São Paulo Medical School

  • Luciana Bertocco Paiva Haddad, MD, PhD · Hospital das Clínicas, University of São Paulo Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-02-29
Completion
2028-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07631689 on ClinicalTrials.gov