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

3 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

132

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Procedura: 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.
Comparatore attivo: Conventional Reperfusion
Standard liver transplantation without discarding the initial reperfusion blood.
Procedura: Standard Liver Transplantation
Conventional liver transplantation without discarding the initial reperfusion blood.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Peak alanine aminotransferase (ALT)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Arterial Pressure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Within 30 days after transplantation.
Complications graded according to the Clavien-Dindo classification.
Within 30 days after transplantation.
ICU length of stay
Lasso di tempo: 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
Lasso di tempo: Up to 30 days after transplantation.
Total hospital length of stay in days.
Up to 30 days after transplantation.
Arterial serum sodium levels
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Sao Paulo General Hospital

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 febbraio 2028

Completamento dello studio (Stimato)

1 febbraio 2028

Date di iscrizione allo studio

Primo inviato

15 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2026

Primo Inserito (Effettivo)

8 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 92854125.8.0000.0068
  • 2025/09932-0 (Altro numero di sovvenzione/finanziamento: São Paulo Research Foundation (FAPESP))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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