The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients: a Randomized Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Postoperative Blood Loss
研究概览
简要总结
It remains still unclear whether topical tranexamic acid has an added value besides the administration of intravenously tranexamic acid. We hypothesize that the addition of topical tranexamic acid, besides intravenous administration of tranexamic acid, results in a 25% reduction of post-operative blood loss after cardiac surgery.
The aim of this study is to determine whether the application of topical tranexamic acid reduces the 12 hours postoperative blood loss by 25% in patient scheduled for cardiac surgery on cardiopulmonary bypass, whereby intravenous tranexamic acid is administrated.
Just before sternal closure, 250 subjects receives pericardial lavage with 2 gr tranexamic acid in 200 ml normothermic saline solution (NaCl 0.9%), 250 subjects receives pericardial lavage with 200 ml normothermic saline solution without TA and 250 subjects (control group) receives no pericardial lavage. The main study parameter is 12 hours post-operative blood loss and is assessed by 12 hours post-operative chest tube production.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender; male/ female
- •Age: ≥ 18 year
- •Elective cardiac surgical patients
- •Coronary artery bypass graft (CABG) (conventional, E.CCO)
- •Aortic valve replacement (AVR) (conventional)
- •Mitral valve replacement (MVR)/ Mitral valve repairment (MPL) (conventional)
- •Tricuspid valve replacement (TVR) / Tricuspid valve repairment (TPL)
- •Combined procedure (e.g. CABG/ AVR, MVR/AVR, AVR/Maze)
排除标准
- •MVR/MPL (minimal invasive, Port Access Surgery)
- •Maze (minimal invasive, via Thoracoscopy)
- •AVR (minimal invasive, via mini Sternotomy)
- •off-pump procedures
- •Emergency operations
- •Patient with increased or decreased blooding tendency (FV leiden, prot C, S deficiency, anti-thrombin deficiency, prothrombin mutation)
研究组 & 干预措施
pericardial lavage with 200 ml normothermic saline solution
According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.
干预措施: Saline (Drug)
2 gr tranexamic acid diluted in 200 ml normothermic saline
According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.
This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).
干预措施: 2 gr tranexamic acid (Drug)
结局指标
主要结局
Postoperative Blood Loss
时间窗: 12 hours postoperative
The primary study parameter is 12 hours postoperative blood loss and is assessed by postoperative chest tube production. Postoperative chest tube production 12 hours after surgical procedure
次要结局
- Number of Participants Requiring Surgical Re-exploration(participants will be followed for the duration of ICU stay, an expected average of 2 days)
- Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period)(participants will be followed for the duration of ICU stay, an expected average of 2 days/ And participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
研究者
Thierry V Scohy
MD, phd
Amphia Hospital