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Oral Versus Intravenous Tranexamic Acid in Off-Pump Coronary Artery Bypass Surgery (TRANSCAB)

30 de julho de 2026 atualizado por: Benjamin JAVILLIER, Clinique Saint-Luc

Oral Versus Intravenous Tranexamic Acid for Blood Loss Prevention in Off-Pump Coronary Artery Bypass Surgery: A Randomized Double-Blind Non-Inferiority Trial

Tranexamic acid is commonly administered intravenously during cardiac surgery to reduce perioperative bleeding. Oral tranexamic acid may offer a simpler and less costly alternative, but its effectiveness in patients undergoing off-pump coronary artery bypass grafting has not been adequately established.

TRANSCAB is a randomized, double-blind, parallel-group, non-inferiority clinical trial comparing oral and intravenous tranexamic acid in adults undergoing elective off-pump coronary artery bypass grafting. Participants will receive either oral tranexamic acid before surgery with an intravenous placebo at induction, or oral placebo before surgery with intravenous tranexamic acid at induction.

The primary objective is to determine whether oral tranexamic acid is non-inferior to intravenous tranexamic acid for reducing postoperative blood loss. Secondary objectives include comparing transfusion requirements, postoperative hemoglobin levels, reoperation for bleeding, thromboembolic complications, seizures, acute kidney injury, and other postoperative outcomes.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Perioperative bleeding remains an important complication of coronary artery bypass surgery and may lead to blood transfusion, reoperation, prolonged hospitalization, and increased postoperative morbidity. Tranexamic acid is an antifibrinolytic drug widely used in cardiac surgery to reduce bleeding and transfusion requirements. It is most commonly administered intravenously, although oral administration may provide adequate systemic exposure while simplifying drug preparation and administration.

TRANSCAB is a monocentric, prospective, randomized, double-blind, placebo-controlled, parallel-group, non-inferiority trial conducted in adult patients undergoing elective off-pump coronary artery bypass grafting.

A total of 160 participants will be randomized in a 1:1 ratio to one of two treatment groups:

  1. Oral tranexamic acid group: four 500 mg tranexamic acid tablets administered approximately 2 hours before surgical incision, together with an intravenous placebo administered at induction or incision according to the study protocol.
  2. Intravenous tranexamic acid group: four matching oral placebo tablets administered approximately 2 hours before surgical incision, together with 1 g intravenous tranexamic acid administered at induction or incision according to the study protocol.

Participants, clinicians involved in perioperative management, outcome assessors, and investigators will remain blinded to treatment allocation. Study treatments will be prepared and dispensed according to the randomization list by the hospital pharmacy.

The primary objective is to assess whether oral tranexamic acid is non-inferior to intravenous tranexamic acid in reducing postoperative blood loss following off-pump coronary artery bypass grafting.

Secondary and safety outcomes will assess perioperative transfusion requirements, postoperative hemoglobin changes, clinically significant bleeding, reoperation for bleeding, thromboembolic events, seizures, acute kidney injury, mortality, duration of intensive care and hospital stay, and other postoperative complications specified in the protocol.

Tipo de estudo

Intervencional

Inscrição (Estimado)

160

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. Age 18 years or older.
  2. Elective isolated coronary artery bypass grafting planned without cardiopulmonary bypass, including off-pump coronary artery bypass through sternotomy or minimally invasive/direct or totally endoscopic coronary artery bypass surgery. Conversion to cardiopulmonary bypass is permitted if clinically required.
  3. Perioperative tranexamic acid planned as part of routine care, with the participant eligible for both oral and intravenous administration according to the applicable product information and local policy.
  4. Written informed consent obtained before randomization.
  5. Routine preoperative laboratory results available, including at least hemoglobin and serum creatinine measured within 30 days before surgery.
  6. Available for in-hospital follow-up and Day 30 assessment.

Exclusion Criteria:

  1. Emergency surgery, non-isolated cardiac surgery, or planned on-pump coronary artery bypass grafting.
  2. Inability to provide informed consent or comply with the required follow-up.
  3. Hypersensitivity to tranexamic acid or any excipient of the study products.

  4. Contraindication or clinically relevant precaution to tranexamic acid according to the applicable product information, including:

    • active arterial or venous thromboembolic disease or active intravascular clotting;
    • history of subarachnoid hemorrhage;
    • acquired defective color vision;
    • clinically relevant seizure disorder or previous tranexamic-acid-associated seizure;
    • disseminated intravascular coagulation without predominant hyperfibrinolysis;
    • active upper urinary tract hematuria with a risk of ureteric obstruction.
  5. Renal function incompatible with the fixed protocol dose, including estimated glomerular filtration rate below 30 mL/min/1.73 m² or dialysis.
  6. Contraindication to either administration route, including inability to swallow tablets, malabsorption precluding oral dosing, or inability to obtain intravenous access.
  7. Pregnancy or breastfeeding.
  8. Participation in another interventional clinical trial that could interfere with study outcomes or safety.
  9. Planned use of another antifibrinolytic agent outside the protocol, including aprotinin or epsilon-aminocaproic acid.
  10. Any new clinical condition identified after randomization but before dosing that, in the investigator's judgment, makes administration of the study treatment unsafe.
  11. Uncontrolled hemodynamic or respiratory instability before administration of the study intervention.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Oral Tranexamic Acid
Participants receive 2 g of oral tranexamic acid as four 500 mg tablets approximately 2 hours before surgical incision, together with an intravenous placebo administered at induction or incision according to the study protocol.
Medicamento: Oral tranexamic acid
Tranexamic acid, 2 g orally, administered as four 500 mg tablets approximately 2 hours before surgical incision.
Medicamento: Intravenous placebo
Intravenous placebo consisting of 50 mL of 0.9% sodium chloride, administered at induction or incision according to the study protocol.
Comparador Ativo: Intravenous Tranexamic Acid
Participants receive four matching oral placebo tablets approximately 2 hours before surgical incision, together with 1 g of intravenous tranexamic acid administered at induction or incision according to the study protocol.
Medicamento: Exacyl®
Tranexamic acid, 1 g intravenously, diluted in 0.9% sodium chloride to a total volume of 50 mL and administered at induction or incision according to the study protocol.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Cumulative Chest Tube Blood Loss Within 24 Hours After Surgery (mL)
Prazo: From completion of surgery to 24 hours postoperatively
Total cumulative volume of blood collected from mediastinal and pleural chest drains during the first 24 hours after completion of surgery, expressed in milliliters.
From completion of surgery to 24 hours postoperatively

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Participants Receiving Red Blood Cell Transfusion
Prazo: From surgery until hospital discharge, up to 30 days
Number and proportion of participants receiving at least one unit of packed red blood cells during surgery or the postoperative hospital stay, and the total number of units transfused per participant.
From surgery until hospital discharge, up to 30 days
Hemoglobin Concentration at 24 Hours After Surgery (g/dL)
Prazo: At 24 hours after surgery
Hemoglobin concentration measured from routine postoperative blood samples, expressed in grams per deciliter.
At 24 hours after surgery
Number of Participants Requiring Reoperation for Bleeding
Prazo: During the index hospitalization, up to 30 days
Number and proportion of participants requiring surgical re-exploration because of postoperative bleeding or cardiac tamponade.
During the index hospitalization, up to 30 days
Number of Participants With Thromboembolic Events
Prazo: From study intervention until 30 days after surgery
Occurrence of clinically diagnosed arterial or venous thromboembolic events, including myocardial infarction, ischemic stroke, deep vein thrombosis, or pulmonary embolism.
From study intervention until 30 days after surgery
Number of Participants With Postoperative Seizures
Prazo: During the index hospitalization, up to 30 days
Occurrence of clinically diagnosed postoperative seizures.
During the index hospitalization, up to 30 days
Number of Participants With Acute Kidney Injury According to Kidney Disease: Improving Global Outcomes (KDIGO) Criteria
Prazo: Within 7 days after surgery or until hospital discharge, whichever occurs first
Number of participants with postoperative acute kidney injury classified according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria (Stages 1, 2, or 3).
Within 7 days after surgery or until hospital discharge, whichever occurs first
Number of Participants With All-Cause Mortality Within 30 Days After Surgery
Prazo: Within 30 days after surgery
Death from any cause.
Within 30 days after surgery
Length of Intensive Care Unit Stay (days)
Prazo: From intensive care unit admission until discharge from the intensive care unit, up to 30 days
Duration of the postoperative intensive care unit stay, expressed in hours or days.
From intensive care unit admission until discharge from the intensive care unit, up to 30 days
Length of Hospital Stay (days)
Prazo: From the date of surgery until hospital discharge, up to 30 days
Duration of the postoperative hospital stay, expressed in days.
From the date of surgery until hospital discharge, up to 30 days

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Clinique Saint-Luc

Investigadores

  • Investigador principal: Benjamin Javillier, MD, Clinique Saint-Luc Bouge

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

1 de junho de 2028

Conclusão do estudo (Estimado)

1 de julho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

28 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de julho de 2026

Primeira postagem (Real)

31 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

31 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • TRANSCAB
  • 2026-526581-24-01 (Ctis)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

De-identified individual participant data underlying the published results may be made available to qualified researchers upon reasonable request. Requests will be reviewed by the Sponsor and Coordinating Investigator and will require an approved research proposal and a signed data use or data transfer agreement. Data sharing will be subject to applicable ethical, legal, regulatory, and data-protection requirements.

Prazo de Compartilhamento de IPD

Beginning 12 months after publication of the primary results and available for 5 years.

Critérios de acesso de compartilhamento IPD

Access may be granted to qualified researchers whose proposed use of the data has been approved by the Sponsor. Requests must include a scientifically sound research proposal and will require a signed data use or data transfer agreement. Data will be shared only in accordance with applicable data-protection, ethical, and regulatory requirements.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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