The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial: Tranexamic Acid (TXA) Versus Placebo to Reduce Perioperative Blood Transfusion in Patients Undergoing Liver Resection: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,386
- 试验地点
- 11
- 主要终点
- Receipt of blood transfusion (% transfused): 7 days
研究概览
简要总结
This is a Phase III multicentre randomized controlled trial (RCT) to evaluate the impact of tranexamic acid (TXA) on perioperative blood transfusion in patients undergoing liver resection. The rationale for this study includes: (1) experimental evidence supporting the use of TXA in other surgical populations; (2) lack of evidence in patients undergoing liver resection; (3) clinical uncertainty and extensive support amongst hepatobiliary surgeons, anaesthesiologists, and hematologists for this proposed trial; (4) a feasible and efficient study design; and (5) the importance of the question: incidence of blood transfusion in patients undergoing liver resection is high, and the consequences serious. The sample size for this study is 1230 participants.Participants enrolled in the prior Vanguard study will proceed directly into the RCT.
详细描述
Purpose Compelling biological rationale and indirect evidence from other settings suggest that there is potential benefit to administering TXA to patients undergoing liver resection. A lack of consensus in the hepatobiliary community and lack of direct evidence in patients undergoing liver resection mandate a RCT.
Hypothesis To determine the impact of perioperative administration of TXA to patients undergoing liver resection on the need for blood transfusion and long-term survival.
Justification If TXA use in liver resection resulted in an important decrease in blood transfusions, clinical practice worldwide would be likely to change. Over 2000 patients in Canada undergo liver resection annually and could benefit from this simple, low-cost intervention. This intervention could easily be implemented in other countries, where many more patients undergo liver resection annually. Furthermore, TXA may be beneficial in other operative fields where bleeding is a major problem, including thoracic surgery, colorectal surgery, and many others.
Objectives
The primary outcome of the RCT will be:
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patient scheduled for open or laparoscopic liver surgery
- •Age ≥18 years
- •Cancer related diagnosis or indication (e.g. pre-cancer, suspicion of cancer, definite cancer)
排除标准
- •Severe anemia (hemoglobin (Hgb) levels <90 g/l)
- •Documented arterial or venous thrombosis at screening or in past three months (not including therapeutic portal vein embolization)
- •Anticoagulants (other than low-molecular-weight heparin (LMWH) or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week
- •Known disseminated intravascular coagulation
- •Severe renal insufficiency (creatinine clearance (CrCl) <30 ml/min)
- •History of seizure disorder
- •Pregnant or lactating (a negative urine pregnancy test must be obtained for women of child bearing potential during the pretreatment evaluation)
- •Acquired disturbance of colour vision
- •Hypersensitivity to TXA or any of the ingredients
- •Unable to receive blood products (i.e. difficulty with cross matching, refuses blood transfusion, or a past history of unexplained severe transfusion reaction)
- •Previously enrolled in this study
研究组 & 干预措施
Tranexamic acid (TXA)
1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours
干预措施: Tranexamic acid (TXA) (Drug)
Normal saline (0.9% sodium chloride)
1 g saline bolus injection + 1 g saline infusion from induction over 8 hours
干预措施: Normal saline (Drug)
结局指标
主要结局
Receipt of blood transfusion (% transfused): 7 days
时间窗: 7 days
Receipt of one or more RBC transfusions between Day 0 and Day 7
次要结局
- Perioperative mortality(7 days)
- Intraoperative blood loss(7 days)
- Number of packed red blood cells (PRBC) units transfused(7 days)
- Postoperative incidence of symptomatic venous thromboembolic event(90 days)
- Recurrence Free Survival (within 5 years of surgery)(60 months)
- Overall Survival (within 5 years of surgery)(60 months)
- Quality of Life (QOL) Assessment using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30(Baseline, 30 days, 90 days)
- Postoperative complications assessed using Clavien-Dindo Grading System(90 days)
- Total blood loss(7 days)
- Quality of Life (QOL) Assessment using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Liver Module (LM)C21 Questionnaire(Baseline, 30 days, 90 days)
- Compare the cost of tranexamic acid (TXA) versus placebo on perioperative blood transfusion in patients undergoing liver resection(90 days)