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

30. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

160

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Belgie
    • Namur
      • Bouge, Namur, Belgie, 5004

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: Oral tranexamic acid
Tranexamic acid, 2 g orally, administered as four 500 mg tablets approximately 2 hours before surgical incision.
Lék: Intravenous placebo
Intravenous placebo consisting of 50 mL of 0.9% sodium chloride, administered at induction or incision according to the study protocol.
Aktivní komparátor: 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.
Lék: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Cumulative Chest Tube Blood Loss Within 24 Hours After Surgery (mL)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants Receiving Red Blood Cell Transfusion
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Within 30 days after surgery
Death from any cause.
Within 30 days after surgery
Length of Intensive Care Unit Stay (days)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Clinique Saint-Luc

Vyšetřovatelé

  • Vrchní vyšetřovatel: Benjamin Javillier, MD, Clinique Saint-Luc Bouge

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. října 2026

Primární dokončení (Odhadovaný)

1. června 2028

Dokončení studie (Odhadovaný)

1. července 2028

Termíny zápisu do studia

První předloženo

28. července 2026

První předloženo, které splnilo kritéria kontroly kvality

30. července 2026

První zveřejněno (Aktuální)

31. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

31. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Časový rámec sdílení IPD

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

Kritéria přístupu pro sdílení 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.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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