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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Benjamin Javillier, MD
- 電話番号：+32 081 20 91 55
- メール：benjamin.javillier@slbo.be
研究場所
-
-
Namur
-
Bouge、Namur、ベルギー、5004
- Clinique Saint-Luc
-
コンタクト：
- Benjamin Javillier, MD
- 電話番号：+32 081209155
- メール：benjamin.javillier@slbo.be
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
アクティブコンパレータ：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cumulative Chest Tube Blood Loss Within 24 Hours After Surgery (mL)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants Receiving Red Blood Cell Transfusion
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Within 30 days after surgery
|
Death from any cause.
|
Within 30 days after surgery
|
|
Length of Intensive Care Unit Stay (days)
時間枠：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)
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Benjamin Javillier, MD、Clinique Saint-Luc Bouge
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- TRANSCAB
- 2026-526581-24-01 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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