Tranexamic Acid to Reduce Infection After Gastrointestinal Surgery; The TRIGS Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,300
- 试验地点
- 1
- 主要终点
- Incidence of Surgical Site Infection
研究概览
简要总结
This international, multicentre, pragmatic, double-blind, placebo-controlled, randomised trial of TxA versus placebo will enrol 3,300 patients throughout Australia and internationally. This is an effectiveness trial - some elements of the trial are deliberately left to the perioperative clinicians' discretion in order to reflect usual practice and maximise generalisability.
详细描述
Study Aims: To conduct a large, multicentre clinical trial of tranexamic acid (TxA), an antifibrinolytic drug routinely used to reduce bleeding in cardiac and some orthopaedic surgery, in 3,300 patients undergoing major gastrointestinal (GI) surgery. Our specific aims are to investigate whether TxA:
Aim 1: Reduces surgical site infection ("wound infection"), and other healthcare-associated infections (pneumonia and sepsis).
Aim 2: Reduces red cell transfusion in GI surgery. Aim 3: Reduces a pooled composite of any serious postoperative complications, and so increases "days alive and at home up to 30 days after surgery" (DAH30).
Aim 4: To evaluate the temporal effect of TxA on perioperative immune and inflammatory responses.
Study Hypothesis Prophylactic TxA administration in patients undergoing major GI surgery reduces the incidence of surgical site infection (SSI) after surgery when compared with placebo.
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)
盲法说明
Matched TxA and placebo vials
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Adult patients scheduled for elective or semi-elective (inpatient) open or lap-assisted GI surgery (oesophageal, gastric, hepatobiliary, colorectal) with one or more risk factors for complications:
- •Age ≥70 years
- •ASA physical status 3 or 4
- •Known or suspected history of: heart failure, diabetes, peripheral vascular disease, or chronic respiratory disease
- •Obesity (BMI ≥30 kg/m2)
- •Anaemia (preoperative haemoglobin <130 g/l in males and <120 g/l in females)
- •Renal impairment (se. creatinine ≥150mol/l)
- •Low albumin (<30 g/L)
排除标准
- •Poor spoken and or written language comprehension
- •Laparoscopic cholecystectomy and other minor (eg. closure of stoma) surgery
- •Pre-existing infection/sepsis
- •Known history of: spontaneous pulmonary embolism, arterial thrombosis familial thrombophilia (e.g. Lupus anticoagulant, protein C deficiency, factor V Leiden)
研究组 & 干预措施
Tranexamic acid
At induction of anesthesia and prior to surgical incision a bolus of 0.15 ml/kg ( up to a maximum of 15 ml) , and then commence an infusion of 0.05 ml/kg/h until the end of surgery. The total maximal administered study drug volume will be 30 ml.
干预措施: Tranexamic Acid (Drug)
Placebo
At induction of anesthesia and prior to surgical incision a bolus of 0.15 ml/kg ( up to a maximum of 15 ml) , and then commence an infusion of 0.05 ml/kg/h until the end of surgery. The total maximal administered study drug volume will be 30 ml.
干预措施: Placebos (Drug)
结局指标
主要结局
Incidence of Surgical Site Infection
时间窗: from surgical incision to 30 days post surgical incision
defined by the US Centers for Disease Control (CDC)
次要结局
- C-reactive protein(Postoperative Day 3 (three days after surgical incision))
- Red cell transfusion(from surgical incision to hospital discharge (from index surgery) or 30 days.)
- Other healthcare-associated infections(from surgical incision to 30 days)
- Days at home up to 30 days after surgery (DAH30).(From surgical incision to 30 days)