Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery: the TRIGS-D Trial (a Substudy of the TRIGS Trial)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 826
- 试验地点
- 1
- 主要终点
- incidence of delirium in the first 3 days postoperatively
研究概览
简要总结
Prophylactic TxA administration in patients undergoing major gastrointestinal surgery reduces the incidence of delirium after surgery when compared with placebo. The unifying hypothesis is that systemic and neuro-inflammation lead to neuronal injury and resultant postoperative delirium.
详细描述
Delirium is a devastating complication of medical and perioperative care, associated with increased morbidity and mortality, dementia and impaired long-term cognition, and loss of independence. Delirium is also associated with neuronal injury placing patients at risk for long-term changes in cognition. There are no proven therapies for postoperative delirium, mainly due to the lack of adequately powered, biologically plausible trials.
There is growing evidence that tranexamic acid (TxA) may reduce inflammatory pathways in the central nervous system and protect the blood-brain barrier in trauma, and surgery.
This sub-study of the TRIGS trial (www.trigs.com.au) is evaluating the potential impact of TxA on the incidence and severity of delirium after surgery.
TRIGS-D Study Aims: In a subset of 826 patients enrolled in the TRIGS randomized trial data will be collected to identify delirium incidence and severity. The specific aims are to investigate whether TxA:
Aim 1: Reduces the incidence of postoperative delirium diagnosed with the 3D-CAM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
TxA blinded for the TRIGS Trial
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tranexamic Acid
12 mg/kg, before surgical incision, and then an infusion of 3 mg/kg/h until the end of surgery.
干预措施: Tranexamic Acid 100Mg/ml Inj Vial 10ml (Drug)
Placebo
12 mg/kg, before surgical incision, and then an infusion of 3 mg/kg/h until the end of surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
incidence of delirium in the first 3 days postoperatively
时间窗: post surgical incision to day 3 (at anytime)obtaining information from the patient, family and staff, and thorough chart review
3D-Confusion Assessment Method (3D-CAM) or CAM-ICU if the Used to measure delirium. Assessments will be conducted twice daily A classification of delirium will be made if both features 1 and 2 are present
次要结局
- perioperative neurocognitive disorders (NCDs)(12 months post surgical incision)
- Delirium severity(post surgical incision to day 3 (inclusive))
- Quality of Life Intergroup differences(12 months post surgical incision)
- Disability(12 months post surgical incision)
- Days at home up to 30 days after surgery (DAH30)(30 days post surgical incision post surgical incision)
- cytokine levels(preoperative, postoperative day 1 and 3 post surgical incision)
- neuronal injury biomarker(preoperative, postoperative day 1 and 3 post surgical incision)