Oral Versus Intravenous Tranexamic Acid in Off-Pump Coronary Artery Bypass Surgery (TRANSCAB)
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.
연구 개요
상태
상세 설명
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:
- 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.
- 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.
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Benjamin Javillier, MD
- 전화번호: +32 081 20 91 55
- 이메일: benjamin.javillier@slbo.be
연구 장소
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Namur
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Bouge, Namur, 벨기에, 5004
- Clinique Saint-Luc
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연락하다:
- Benjamin Javillier, MD
- 전화번호: +32 081209155
- 이메일: benjamin.javillier@slbo.be
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18 years or older.
- 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.
- 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.
- Written informed consent obtained before randomization.
- Routine preoperative laboratory results available, including at least hemoglobin and serum creatinine measured within 30 days before surgery.
- Available for in-hospital follow-up and Day 30 assessment.
Exclusion Criteria:
- Emergency surgery, non-isolated cardiac surgery, or planned on-pump coronary artery bypass grafting.
- Inability to provide informed consent or comply with the required follow-up.
- Hypersensitivity to tranexamic acid or any excipient of the study products.
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.
- Renal function incompatible with the fixed protocol dose, including estimated glomerular filtration rate below 30 mL/min/1.73 m² or dialysis.
- Contraindication to either administration route, including inability to swallow tablets, malabsorption precluding oral dosing, or inability to obtain intravenous access.
- Pregnancy or breastfeeding.
- Participation in another interventional clinical trial that could interfere with study outcomes or safety.
- Planned use of another antifibrinolytic agent outside the protocol, including aprotinin or epsilon-aminocaproic acid.
- Any new clinical condition identified after randomization but before dosing that, in the investigator's judgment, makes administration of the study treatment unsafe.
- Uncontrolled hemodynamic or respiratory instability before administration of the study intervention.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
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Tranexamic acid, 2 g orally, administered as four 500 mg tablets approximately 2 hours before surgical incision.
Intravenous placebo consisting of 50 mL of 0.9% sodium chloride, administered at induction or incision according to the study protocol.
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활성 비교기: 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.
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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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cumulative Chest Tube Blood Loss Within 24 Hours After Surgery (mL)
기간: From completion of surgery to 24 hours postoperatively
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Total cumulative volume of blood collected from mediastinal and pleural chest drains during the first 24 hours after completion of surgery, expressed in milliliters.
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From completion of surgery to 24 hours postoperatively
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants Receiving Red Blood Cell Transfusion
기간: From surgery until hospital discharge, up to 30 days
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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.
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From surgery until hospital discharge, up to 30 days
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Hemoglobin Concentration at 24 Hours After Surgery (g/dL)
기간: At 24 hours after surgery
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Hemoglobin concentration measured from routine postoperative blood samples, expressed in grams per deciliter.
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At 24 hours after surgery
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Number of Participants Requiring Reoperation for Bleeding
기간: During the index hospitalization, up to 30 days
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Number and proportion of participants requiring surgical re-exploration because of postoperative bleeding or cardiac tamponade.
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During the index hospitalization, up to 30 days
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Number of Participants With Thromboembolic Events
기간: From study intervention until 30 days after surgery
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Occurrence of clinically diagnosed arterial or venous thromboembolic events, including myocardial infarction, ischemic stroke, deep vein thrombosis, or pulmonary embolism.
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From study intervention until 30 days after surgery
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Number of Participants With Postoperative Seizures
기간: During the index hospitalization, up to 30 days
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Occurrence of clinically diagnosed postoperative seizures.
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During the index hospitalization, up to 30 days
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Number of Participants With Acute Kidney Injury According to Kidney Disease: Improving Global Outcomes (KDIGO) Criteria
기간: Within 7 days after surgery or until hospital discharge, whichever occurs first
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Number of participants with postoperative acute kidney injury classified according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria (Stages 1, 2, or 3).
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Within 7 days after surgery or until hospital discharge, whichever occurs first
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Number of Participants With All-Cause Mortality Within 30 Days After Surgery
기간: Within 30 days after surgery
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Death from any cause.
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Within 30 days after surgery
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Length of Intensive Care Unit Stay (days)
기간: From intensive care unit admission until discharge from the intensive care unit, up to 30 days
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Duration of the postoperative intensive care unit stay, expressed in hours or days.
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From intensive care unit admission until discharge from the intensive care unit, up to 30 days
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Length of Hospital Stay (days)
기간: From the date of surgery until hospital discharge, up to 30 days
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Duration of the postoperative hospital stay, expressed in days.
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From the date of surgery until hospital discharge, up to 30 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Benjamin Javillier, MD, Clinique Saint-Luc Bouge
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- TRANSCAB
- 2026-526581-24-01 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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