A Phase IV Trial of a Hospital Policy of Tranexamic Acid Use to Reduce Transfusion in Major Non-cardiac Surgery (TRACTION): A Pragmatic Randomized Cluster Crossover Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8,421
- 试验地点
- 9
- 主要终点
- Proportion of patients transfused RBCs
研究概览
简要总结
A Phase IV trial of a hospital policy of Tranexamic acid to reduce transfusion in major non-cardiac surgery.
详细描述
The TRACTION Trial is a national multi-centre Phase IV randomized cluster-crossover trial of Tranexamic acid versus placebo. Over the duration of the study, participating centres will be centrally and randomly allocated to receive either TXA or matching placebo at 1-month intervals. As our pragmatic trial is designed to define practice, we have selected co-primary outcomes that evaluate effectiveness in the context of safety.
Our co-primary outcomes are the:
- Proportion of patients transfused RBCs
- Incidence of DVT or PE (collectively called venous thromboembolism (VTE) within 90 days of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Over the duration of the study, participating centres will be centrally and randomly allocated to receive either TXA or matching placebo at 1-month intervals for a total of 8 months. Intervention assignment will only be known to the research pharmacy staff who will prepare the study drug specific to the interval assignment. To minimize sources of selection and ascertainment biases, anesthesiologists, surgeons, investigators, research staff, and members of the Data Safety and Monitoring Board will all be blinded to randomization schemes and treatments administered; only the trial statistician will have access to randomization schemes for all sites. The research site's Pharmacy staff will not have contact with the study team or the patient and will be expressly forbidden to discuss individual treatment allocation with the study team, the patient, the operating room and clinical care team unless emergency un-blinding is warranted.
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
- •Cluster-level inclusion criteria:
- •Hospital sites will be included in the trial if the site performs ≥ 100 noncardiac surgeries per month, and if anesthesia, surgery and hospital leadership agree to manage patients as per the policy being implemented and evaluated in the trial.
- •Patient-level inclusion criteria:
- •Patients >/= 18 years of age undergoing major non-cardiac surgery (a state of hyperfibrinolysis)
- •Inpatient surgeries with an estimated >/= 5% risk of RBC transfusion, including open surgeries or laparoscopic surgeries with an estimated duration of >/= 3 hours
- •Examples of eligible surgeries could include (but are not limited to):
- •General surgery (esophagectomy, gastrectomy, gastric repair, small bowel repair or resection, ostomy formation, colon/rectum repair or resection, colostomy, splenectomy, hepatectomy, pancreatectomy, resection of abdominal mass)
- •Orthopedics (hip fracture repair, pelvic fixation, femur repair / fixation, shoulder / humerus open reduction internal fixation, lower extremity amputation)
- •Spine (vertebrectomy, surgery involving >/= 3 levels)
- •Otolaryngology (glossectomy, mandibulectomy, radical laryngectomy)
- •Thoracic (lung resection or decortication)
- •Vascular (arterial bypass / endarterectomy / aneurysmorrhaphy involving the aorta or proximal vessels off the aorta)
- •Gynecology (hysterectomy)
- •Urology (nephrectomy, cystectomy, prostatectomy, pelvic exenteration)
- •Plastic surgery (large neoplasm resections, burns or debridements)
- •Surgeries anticipated to be associated with 5% or greater risk of RBC transfusion in hospital as per the surgical team.
排除标准
- •Active thromboembolic disease (i.e., arterial or venous thrombosis within 90 days preoperative)
- •Pregnancy
- •Cardiac surgery and hip and knee arthroplasty where TXA is standard-of-care
- •Surgeries with free flap reconstruction
- •Trauma surgeries where TXA was administered within the previous 3 hours.
研究组 & 干预措施
Tranexamic acid (TXA) Arm
TXA 1 gram bolus (2 grams for patients over 100 kg) intravenously (IV) administered within 10 minutes of the first surgical incision, followed by 1 additional gram given intravenously at 2-4 hours of surgery or prior to skin closure, at the discretion of the anesthesiologist (e.g. IV bolus at 2-4 hours of surgery, at skin closure, or the 1 additional gram given as a continuous infusion throughout the surgical procedure).
干预措施: Tranexamic acid (TXA) (Drug)
Placebo Arm
Placebo 1 gram bolus (2 grams for patients over 100 kg) intravenously (IV) administered within 10 minutes of the first surgical incision, followed by 1 additional gram given intravenously at 2-4 hours of surgery or prior to skin closure, at the discretion of the anesthesiologist (e.g. IV bolus at 2-4 hours of surgery, at skin closure, or the 1 additional gram given as a continuous infusion throughout the surgical procedure).
干预措施: Placebo (0.9 % Saline) (Drug)
结局指标
主要结局
Proportion of patients transfused RBCs
时间窗: From date of surgery until the date of hospital discharge, assessed up to 90 days
Proportion of patients requiring transfused RBCs
Incidence of DVT or PE (collectively called venous thromboembolism (VTE)
时间窗: Within 90 days of surgery
Number of patients with VTE events
次要结局
- Transfused units(From date of surgery until 3 days post-operative, 7 days post-operative, and until the date of hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.)
- Arterial event - myocardial infarction(Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.)
- Arterial event - stroke(Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.)
- Venous thrombotic event - deep vein thrombosis(Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.)
- Venous thrombotic event - pulmonary embolus(Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.)
- Length of hospitalization(Length of index hospital admission)
- Intensive care unit (ICU) admission(Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.)
- Hospital survival(Hospital discharge. The estimated mean hospital length of stay is anticipated to be <7 days.)
- 90 day survival(Up to day 30)
- Compliance(Intraoperative)
- Clinical -a patient centered outcome(Up to day 30 postoperative)
研究者
Dr. Ryan Zarychanski
Nominated Principal Investigator
University of Manitoba