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

3. Juni 2026 aktualisiert von: Joel Avancini Rocha Filho, University of Sao Paulo General Hospital

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.

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

132

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Reperfusion Blood Discard
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
Verfahren: 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.
Aktiver Komparator: Conventional Reperfusion
Standard liver transplantation without discarding the initial reperfusion blood.
Verfahren: Standard Liver Transplantation
Conventional liver transplantation without discarding the initial reperfusion blood.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Peak alanine aminotransferase (ALT)
Zeitfenster: Within 72 hours after transplantation
Peak serum ALT level (U/L) as a biomarker of early graft injury following liver transplantation.
Within 72 hours after transplantation

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Arterial Pressure
Zeitfenster: Intraoperative, during reperfussion, 30 minutes after reperfusion, and postoperative day 1.
Monitoring arterial pressure (systolic, diastolic e medium) Unit of Measure: mmHg.
Intraoperative, during reperfussion, 30 minutes after reperfusion, and postoperative day 1.
Cardiac Rhythm
Zeitfenster: Intraoperative, during reperfussion, 30 minutes after reperfusion, and postoperative day 1
Cardiac rhythm monitoring with electrocardiography in ECG lead 2 and V5
Intraoperative, during reperfussion, 30 minutes after reperfusion, and postoperative day 1
Cardiac Output
Zeitfenster: Intraoperative, during reperfussion, 30 minutes after reperfusion, and postoperative day 1.
Monitoring continuous cardiac output. Unit of Measure: L/min.
Intraoperative, during reperfussion, 30 minutes after reperfusion, and postoperative day 1.
Arterial serum potassium levels
Zeitfenster: Intraoperative and daily from postoperative day 1 up to day 7.
Perioperative changes in arterial potassium levels (Unit of measure: mEq/L).
Intraoperative and daily from postoperative day 1 up to day 7.
Blood coagulation thromboelastometry
Zeitfenster: Intraoperative (at the start of surgery, 5 minutes after reperfusion, and at the end of surgery).
Assessment of intraoperative coagulation changes using rotational thromboelastometry (ROTEM), including EXTEM and FIBTEM parameters, and activated clotting time (ACT).
Intraoperative (at the start of surgery, 5 minutes after reperfusion, and at the end of surgery).
International normalized ratio (INR)
Zeitfenster: Daily up to 72 hours after transplantation.
Assessment of graft function using international normalized ratio (INR).
Daily up to 72 hours after transplantation.
Aspartate aminotransferase levels (AST)
Zeitfenster: Daily up to 7 days and weekly up to 30 days after transplantation.
Assessment of graft injury using serum levels of AST (Unit of measure: U/L).
Daily up to 7 days and weekly up to 30 days after transplantation.
Serum Tumor Necrosis Factor-alpha (TNF-α)
Zeitfenster: At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.
Serum levels of inflammatory mediator TNF-α (Unit of measure: pg/mL).
At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.
Serum B-type natriuretic peptide (BNP)
Zeitfenster: At the start of surgery, 30 minutes after reperfusion and postoperative day 1.
Assessment of BNP levels as a marker of cardiac hemodynamic stress. Unit of Measure: pg/mL.
At the start of surgery, 30 minutes after reperfusion and postoperative day 1.
Serum creatinine levels
Zeitfenster: Up to 30 days after transplantation.
Assessment of serum creatinine levels to evaluate renal function (Unit of measure: mg/dL),
Up to 30 days after transplantation.
Postoperative complications
Zeitfenster: Within 30 days after transplantation.
Complications graded according to the Clavien-Dindo classification.
Within 30 days after transplantation.
ICU length of stay
Zeitfenster: Up to 30 days after transplantation.
Days of length of stay in the intensive care unit.
Up to 30 days after transplantation.
Hospital length of stay
Zeitfenster: Up to 30 days after transplantation.
Total hospital length of stay in days.
Up to 30 days after transplantation.
Arterial serum sodium levels
Zeitfenster: Intraoperative and daily from postoperative day 1 up to day 7.
Perioperative changes in arterial serum sodium levels (Unit of measure: mEq/L).
Intraoperative and daily from postoperative day 1 up to day 7.
Arterial serum lactate levels
Zeitfenster: Intraoperative and daily from postoperative day 1 up to day 7.
Perioperative changes in arterial serum lactate levels (Unit of measure mg/dL),
Intraoperative and daily from postoperative day 1 up to day 7.
Arterial serum calcium levels
Zeitfenster: Intraoperative and daily from postoperative day 1 up to day 7.
Perioperative changes in arterial serum calcium levels (Unit of measure mg/dL),
Intraoperative and daily from postoperative day 1 up to day 7.
Serum glucose levels
Zeitfenster: Intraoperative and daily from postoperative day 1 up to day 7.
Perioperative changes in serum glucose levels (Unit of measure: mg/dL).
Intraoperative and daily from postoperative day 1 up to day 7.
Arterial serum pH
Zeitfenster: Intraoperative and daily from postoperative day 1 up to day 7.
Perioperative changes in arterial pH units.
Intraoperative and daily from postoperative day 1 up to day 7.
Arterial serum bicarbonate
Zeitfenster: Intraoperative and daily from postoperative day 1 up to day 7.
Perioperative changes in arterial serum bicarbonate (Unit of measure mmol/L)
Intraoperative and daily from postoperative day 1 up to day 7.
Factor V activity levels
Zeitfenster: Daily up to 72 hours after transplantation .
Assessment of graft function using Factor V activity levels measure as percentage.
Daily up to 72 hours after transplantation .
Alkaline phosphatase levels
Zeitfenster: Daily up to 7 days and weekly up to 30 days after transplantation.
Assessement of graft function using alkaline phosphatase levels (Unit of measure: U/L),
Daily up to 7 days and weekly up to 30 days after transplantation.
Gamma-glutamyl transferase levels
Zeitfenster: Daily up to 7 days and weekly up to 30 days after transplantation.
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).
Daily up to 7 days and weekly up to 30 days after transplantation.
Serum ammonia levels
Zeitfenster: Daily up to 7 days and weekly up to 30 days after transplantation.
Assessment of serum ammonia levels to evaluate liver function.(Unit of measure: mcmol/L).
Daily up to 7 days and weekly up to 30 days after transplantation.
Serum urea levels
Zeitfenster: Up to 30 days after transplantation.
Assessment of serum urea levels to evaluate renal function (Unit of measure: mg/dl),
Up to 30 days after transplantation.
Urine output
Zeitfenster: Up to 30 days after transplantation.
Assessment of renal function measured by daily urine output.
Up to 30 days after transplantation.
Need for renal replacement therapy
Zeitfenster: Up to 30 days after transplantation.
Need for renal replacement therapy (hemodialysis or continuous renal replacement therapy).
Up to 30 days after transplantation.
Serum Interleukin-6 (IL-6) levels
Zeitfenster: At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.
Serum levels of inflammatory mediator IL-6 (Unit of measure: pg/mL),
At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.
Serum Tumor Necrosis Factor-alpha (TNF-α) levels
Zeitfenster: At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.
Serum levels of inflammatory mediator TNF-α levels. (Unit of measure: pg/mL)
At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.
Serum Interleukin-17 (IL-17) levels
Zeitfenster: At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.
Serum levels of inflammatory mediator IL-17 (Unit of measure: pg/mL).
At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Sao Paulo General Hospital

Ermittler

  • Hauptermittler: Joel Avancini Rocha Filho, MD, PhD, Hospital das Clínicas, University of São Paulo Medical School
  • Studienleiter: Estela Regina Ramos Figueira, MD, PhD, Hospital das Clínicas, University of São Paulo Medical School
  • Studienleiter: Maria Jose Carvalho Carmona, MD, PhD, Hospital das Clínicas, University of São Paulo Medical School
  • Studienleiter: Wellington Andraus, MD, PhD, Hospital das Clínicas, University of São Paulo Medical School
  • Studienleiter: Rui Carlos Detsch Junior, MD, Hospital das Clínicas, University of São Paulo Medical School
  • Studienleiter: Luciana Bertocco Paiva Haddad, MD, PhD, Hospital das Clínicas, University of São Paulo Medical School

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Februar 2028

Studienabschluss (Geschätzt)

1. Februar 2028

Studienanmeldedaten

Zuerst eingereicht

15. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Juni 2026

Zuerst gepostet (Tatsächlich)

8. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Juni 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 92854125.8.0000.0068
  • 2025/09932-0 (Andere Zuschuss-/Finanzierungsnummer: São Paulo Research Foundation (FAPESP))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be shared due to institutional and privacy considerations.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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