Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

30 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

160

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Oral tranexamic acid
Tranexamic acid, 2 g orally, administered as four 500 mg tablets approximately 2 hours before surgical incision.
Médicament: Intravenous placebo
Intravenous placebo consisting of 50 mL of 0.9% sodium chloride, administered at induction or incision according to the study protocol.
Comparateur actif: 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.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Cumulative Chest Tube Blood Loss Within 24 Hours After Surgery (mL)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Participants Receiving Red Blood Cell Transfusion
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Within 30 days after surgery
Death from any cause.
Within 30 days after surgery
Length of Intensive Care Unit Stay (days)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Clinique Saint-Luc

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

1 juin 2028

Achèvement de l'étude (Estimé)

1 juillet 2028

Dates d'inscription aux études

Première soumission

28 juillet 2026

Première soumission répondant aux critères de contrôle qualité

30 juillet 2026

Première publication (Réel)

31 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

31 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage IPD

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

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner