AzTrials
AzTrials

Liver TransplantationNCT07631689

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

A study testing Reperfusion Blood Discard and Standard Liver Transplantation in people with Liver Transplantation and Ischaemia Reperfusion Injury, run by University of Sao Paulo General Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Hepatic reperfusion during liver transplantation remains a critical phase associated with significant hemodynamic and systemic disturbances, despite advances in surgical and anesthetic management. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Reperfusion Blood Discard and Standard Liver Transplantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
No sites listed yet
Study dates
Jul 2026to Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

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

About this study

Official title: Assessment of the Impact of Discarding the Initial Reperfusion Blood on Early Liver Function, Cardiovascular and Metabolic Changes and on 30-Day Liver and Renal Outcomes. A Prospective Randomized Trial in Liver Transplantation

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.

Read more

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.

Read the detailed description

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 compromise immediate intraoperative stability and have been associated with adverse short- and long-term outcomes for both the recipient and the graft.

The abrupt restoration of blood flow to the transplanted liver results in the systemic release of accumulated metabolites, reactive oxygen species, and inflammatory mediators, triggering a systemic inflammatory response that may extend beyond the liver and affect distant organs, including the kidneys and heart.

Several revascularization strategies have been investigated to mitigate reperfusion-related injury, including portal vein, hepatic artery, and simultaneous reperfusion approaches. However, none have consistently demonstrated a clear benefit in reducing ischemia-reperfusion injury or improving clinical outcomes. An alternative and less explored strategy involves diverting and discarding the initial reperfusion blood from the graft before restoring venous outflow to the systemic circulation.

Patients listed for liver transplantation at the study center will be systematically screened for eligibility. Written informed consent will be obtained from all eligible participants prior to enrollment, in accordance with institutional ethical standards.

This study is a prospective randomized clinical trial designed to evaluate whether discarding the initial reperfusion blood via the infrahepatic vena cava attenuates early hemodynamic, metabolic, and inflammatory disturbances and improves postoperative outcomes compared with conventional reperfusion techniques.

Being tested
Reperfusion Blood Discard, Standard Liver Transplantation
Keywords
liver transplantation, ischemia-reperfusion injury, liver graft function, anesthesia, inflamatory response, perioperative complications, hemodynamics
Medical subject headings
Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reperfusion Blood DiscardProcedure or surgery

    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.

  • Standard Liver TransplantationProcedure or surgery

    Conventional liver transplantation without discarding the initial reperfusion blood.

Study groups in NCT07631689
Study groupRoleWhat they receive
Reperfusion Blood DiscardExperimentalLiver 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
Receives: Procedure: Reperfusion Blood Discard
Conventional ReperfusionActive comparatorStandard liver transplantation without discarding the initial reperfusion blood.
Receives: Procedure: Standard Liver Transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak alanine aminotransferase (ALT)

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

    Measured: Within 72 hours after transplantation

Secondary outcomes (29)
  1. Arterial Pressure

    Monitoring arterial pressure (systolic, diastolic e medium) Unit of Measure: mmHg.

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

  2. Cardiac Rhythm

    Cardiac rhythm monitoring with electrocardiography in ECG lead 2 and V5

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

  3. Cardiac Output

    Monitoring continuous cardiac output. Unit of Measure: L/min.

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

  4. Arterial serum potassium levels

    Perioperative changes in arterial potassium levels (Unit of measure: mEq/L).

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

  5. Blood coagulation thromboelastometry

    Assessment of intraoperative coagulation changes using rotational thromboelastometry (ROTEM), including EXTEM and FIBTEM parameters, and activated clotting time (ACT).

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

  6. International normalized ratio (INR)

    Assessment of graft function using international normalized ratio (INR).

    Measured: Daily up to 72 hours after transplantation.

  7. Aspartate aminotransferase levels (AST)

    Assessment of graft injury using serum levels of AST (Unit of measure: U/L).

    Measured: Daily up to 7 days and weekly up to 30 days after transplantation.

  8. Serum Tumor Necrosis Factor-alpha (TNF-α)

    Serum levels of inflammatory mediator TNF-α (Unit of measure: pg/mL).

    Measured: At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.

  9. Serum B-type natriuretic peptide (BNP)

    Assessment of BNP levels as a marker of cardiac hemodynamic stress. Unit of Measure: pg/mL.

    Measured: At the start of surgery, 30 minutes after reperfusion and postoperative day 1.

  10. Serum creatinine levels

    Assessment of serum creatinine levels to evaluate renal function (Unit of measure: mg/dL),

    Measured: Up to 30 days after transplantation.

  11. Postoperative complications

    Complications graded according to the Clavien-Dindo classification.

    Measured: Within 30 days after transplantation.

  12. ICU length of stay

    Days of length of stay in the intensive care unit.

    Measured: Up to 30 days after transplantation.

  13. Hospital length of stay

    Total hospital length of stay in days.

    Measured: Up to 30 days after transplantation.

  14. Arterial serum sodium levels

    Perioperative changes in arterial serum sodium levels (Unit of measure: mEq/L).

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

  15. Arterial serum lactate levels

    Perioperative changes in arterial serum lactate levels (Unit of measure mg/dL),

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

  16. Arterial serum calcium levels

    Perioperative changes in arterial serum calcium levels (Unit of measure mg/dL),

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

  17. Serum glucose levels

    Perioperative changes in serum glucose levels (Unit of measure: mg/dL).

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

  18. Arterial serum pH

    Perioperative changes in arterial pH units.

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

  19. Arterial serum bicarbonate

    Perioperative changes in arterial serum bicarbonate (Unit of measure mmol/L)

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

  20. Factor V activity levels

    Assessment of graft function using Factor V activity levels measure as percentage.

    Measured: Daily up to 72 hours after transplantation .

  21. Alkaline phosphatase levels

    Assessement of graft function using alkaline phosphatase levels (Unit of measure: U/L),

    Measured: Daily up to 7 days and weekly up to 30 days after transplantation.

  22. Gamma-glutamyl transferase levels

    Assessment of liver function using serum levels of gamma-glutamyl transferase up to 7 days and weekly up to 30 days after transplantation (Unit of measure: U/L).

    Measured: Daily up to 7 days and weekly up to 30 days after transplantation.

  23. Serum ammonia levels

    Assessment of serum ammonia levels to evaluate liver function.(Unit of measure: mcmol/L).

    Measured: Daily up to 7 days and weekly up to 30 days after transplantation.

  24. Serum urea levels

    Assessment of serum urea levels to evaluate renal function (Unit of measure: mg/dl),

    Measured: Up to 30 days after transplantation.

  25. Urine output

    Assessment of renal function measured by daily urine output.

    Measured: Up to 30 days after transplantation.

  26. Need for renal replacement therapy

    Need for renal replacement therapy (hemodialysis or continuous renal replacement therapy).

    Measured: Up to 30 days after transplantation.

  27. Serum Interleukin-6 (IL-6) levels

    Serum levels of inflammatory mediator IL-6 (Unit of measure: pg/mL),

    Measured: At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.

  28. Serum Tumor Necrosis Factor-alpha (TNF-α) levels

    Serum levels of inflammatory mediator TNF-α levels. (Unit of measure: pg/mL)

    Measured: At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.

  29. Serum Interleukin-17 (IL-17) levels

    Serum levels of inflammatory mediator IL-17 (Unit of measure: pg/mL).

    Measured: At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionFeb 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07631689
Sponsor's protocol ID
92854125.8.0000.0068
Other IDs
2025/09932-0, 2025
Status last verified
Apr 2026
First submitted
15 Apr 2026
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to institutional and privacy considerations.

Questions about this trial

What is this clinical trial studying?

A study testing Reperfusion Blood Discard and Standard Liver Transplantation in people with Liver Transplantation and Ischaemia Reperfusion Injury, run by University of Sao Paulo General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joel Avancini Rocha Filho, MD, PhD (+55 11 981422500, joel.rocha@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak alanine aminotransferase (ALT) (time frame: Within 72 hours after transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in