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

NCT07631689 | Not Yet Recruiting

• 2 other identifiers: 92854125.8.0000.00682025/09932-0
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

liver transplantation; ischemia-reperfusion injury; liver graft function; anesthesia; inflamatory response; perioperative complications; hemodynamics

Outcome Measures

Primary Outcomes (1)

• Peak alanine aminotransferase (ALT)

  Peak serum ALT level (U/L) as a biomarker of early graft injury following liver transplantation.

  Within 72 hours after transplantation

Secondary Outcomes (29)

• Arterial Pressure

  Intraoperative, during reperfussion, 30 minutes after reperfusion, and postoperative day 1.

• Cardiac Rhythm

  Intraoperative, during reperfussion, 30 minutes after reperfusion, and postoperative day 1

• Cardiac Output

  Intraoperative, during reperfussion, 30 minutes after reperfusion, and postoperative day 1.

• Arterial serum potassium levels

  Intraoperative and daily from postoperative day 1 up to day 7.

• Blood coagulation thromboelastometry

  Intraoperative (at the start of surgery, 5 minutes after reperfusion, and at the end of surgery).

Study Arms (2)

Reperfusion Blood Discard

EXPERIMENTAL

Liver transplantation with discarding of the initial 180 mL of reperfusion blood via the infrahepatic vena cava prior to restoration of hepatic blood outflow to the systemic circulation

Procedure: Reperfusion Blood Discard

Conventional Reperfusion

ACTIVE COMPARATOR

Standard liver transplantation without discarding the initial reperfusion blood.

Procedure: Standard Liver Transplantation

Interventions

Reperfusion Blood Discard PROCEDURE

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.

Reperfusion Blood Discard

Standard Liver Transplantation PROCEDURE

Conventional liver transplantation without discarding the initial reperfusion blood.

Conventional Reperfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• Candidates for liver transplantation at Hospital das Clínicas, University of São Paulo Medical School (HCFMUSP)
• Able to provide written informed consent

You may not qualify if:

• Inability to provide informed consent
• Previous liver surgery
• Fulminant hepatitis
• Specific liver diseases associated with severe electrolyte disturbances
• End-stage renal disease requiring dialysis
• Combined organ transplantation
• Living donor liver transplantation
• Liver retransplantation
• Highly sensitized patients with limited availability of blood products
• Hematologic diseases
• Portal vein thrombosis involving more than 50% of the lumen
• Portopulmonary hypertension (mean pulmonary artery pressure \> 20 mmHg), diagnosed preoperatively or intraoperatively

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joel Avancini Rocha Filho, MD, PhD

  Hospital das Clínicas, University of São Paulo Medical School

  PRINCIPAL INVESTIGATOR

• Estela Regina Ramos Figueira, MD, PhD

  Hospital das Clínicas, University of São Paulo Medical School

  STUDY DIRECTOR

• Maria Jose Carvalho Carmona, MD, PhD

  Hospital das Clínicas, University of São Paulo Medical School

  STUDY DIRECTOR

• Wellington Andraus, MD, PhD

  Hospital das Clínicas, University of São Paulo Medical School

  STUDY DIRECTOR

• Rui Carlos Detsch Junior, MD

  Hospital das Clínicas, University of São Paulo Medical School

  STUDY DIRECTOR

• Luciana Bertocco Paiva Haddad, MD, PhD

  Hospital das Clínicas, University of São Paulo Medical School

  STUDY DIRECTOR

Central Study Contacts

Joel Avancini Rocha Filho, MD, PhD

CONTACT

+55 11 981422500; joel.rocha@hc.fm.usp.br

Estela Regina Ramos Figueira, MD, PhD

CONTACT

+55 11 999454871; estela.figueira@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Due to the nature of the surgical intervention, blinding is not feasible. Outcomes will be assessed using objective clinical and laboratory measures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Collaborating Professor and Liver Transplant Anesthesia Supervisor, Hospital das Clínicas, University of São Paulo Medical School (HCFMUSP)

Model Details: Participants will be randomized in a 1:1 ratio to one of two groups: liver transplantation with discarding of the initial reperfusion blood or conventional liver transplantation without discard. The study follows a parallel-group design to compare the effects of the intervention on early graft function, hemodynamic stability, and postoperative outcomes.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: June 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share