Prospective, Randomized, Double Blind Study on the Effects of Tranexamic Acid on Intraoperative Blood Loss During Lumbar Spinal Fusion And Instrumentation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Delirium Occurrence
研究概览
简要总结
Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels. Information regarding blood loss, transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation and duration of hospital stay will be collected.
详细描述
This study is to assess whether tranexamic acid (a drug that is used to coagulate the blood and reduce bleeding) use in lumbar spinal fusion can reduce blood loss and postoperative delirium compared to placebo. Thusly reducing need for transfusion, shorting the hospital stay and improving outcomes. For this the study will randomize patients who are receiving elective lumbar interbody fusion (PLIF or TLIF) of 2 or more levels for degenerative disc disease (DDD) into 2 groups. Group 1 would receive tranexamic acid during the surgery while group 2 will receive placebo. Blood loss during the surgery and postoperatively (while the patient has a drain) will be monitored along with the amount of transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation, and and the duration of hospital stay. Delirium occurrence and severity will be assessed daily for the first 5 days after surgery or at discharge, whichever comes first. Cognitive status (neuropsychological tests) will be assessed at post-discharge follow up visits and compared to preoperative status.
The drug or placebo are only given during the surgery. The patient population includes elective cases of patient undergoing lumbar spinal fusion of 2 or more levels. Spinal fusions are known to be associated with blood loss, especially when the surgeries are long and more levels need to be fused.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-90 years
- •American Spinal Injury Association (ASA) Impairment Scale anesthesia risk of I to IV
- •Patients undergoing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF.
- •Patients have failed conservative management, which include physical therapy (PT) or occupational therapy (OT) and/or injections.
排除标准
- •ASA class V
- •Patient unable to consent
- •Patient with chronic kidney disease stage III or above: baseline plasma creatinine>1.5mg/dL
- •Patient with known liver failure
- •Patients on anticoagulation or dual antiplatelets (presence of vascular stents).
- •Patients with artificial valves.
- •Patients with allergy to TXA
- •Patients with platelet count < 150 000,
- •Patients with PT>15s
- •Patients with Activated Partial Thromboplastin Time (APPT) >38s
- •History of stroke or (an) unprovoked thromboembolic event(s).
- •History of intracranial bleeding,
- •known defective color vision
- •history of venous or arterial thromboembolism or active thromboembolic disease
- •Patients with severe pulmonary or cardiac disease.
- •Patients who refuse transfusion of blood products
- •Patients with chronic anemia with Hg<8
- •Patients undergoing lumbar fusion for disease other than DDD (neoplasm)
- •Patients undergoing lumbar fusion by anterior or lateral approach.
- •Minimally invasive TLIF are excluded.
- •Emergent cases.
- •Women on hormonal contraception
- •Retinal vein or artery occlusion
- •Hypercoagulability
- •Seizure disorder
- •Current use of tretinoin
- •Current use of chlorpromazine
- •Breast feeding
研究组 & 干预措施
Treatment
1:1 randomization, given tranexamic acid during surgery, visual acuity exam
干预措施: Tranexamic Acid (Drug)
Treatment
1:1 randomization, given tranexamic acid during surgery, visual acuity exam
干预措施: Visual Acuity Exam (Diagnostic Test)
Treatment
1:1 randomization, given tranexamic acid during surgery, visual acuity exam
干预措施: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) (Diagnostic Test)
Placebo
1:1 randomization, given standard of care treatment during surgery, visual acuity exam
干预措施: Saline Solution (Drug)
Placebo
1:1 randomization, given standard of care treatment during surgery, visual acuity exam
干预措施: Visual Acuity Exam (Diagnostic Test)
Placebo
1:1 randomization, given standard of care treatment during surgery, visual acuity exam
干预措施: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) (Diagnostic Test)
结局指标
主要结局
Delirium Occurrence
时间窗: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
Delirium occurrence (yes/no) using daily 3D-CAM delirium assessment instrument.
Transfusion
时间窗: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
The number of participants who had red blood cells (RBC) transfused: 1. Intraoperatively 2. Postoperatively (prior to discharge or at day 5, whichever occurred first) 3. Either Intraoperatively or Postoperatively
Blood Loss
时间窗: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
Amount of blood loss: 1. Intraoperatively 2. Postoperatively (prior to discharge or at day 5, whichever occurred first) 3. Either Intraoperatively or Postoperatively
次要结局
- Length of Postoperative Stay Prior to Discharge(Days thru day of discharge)
- Delirium Severity(Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported)
- Change in Interleukin-6 Concentration.(Preoperatively and 24 hours postoperatively)
研究者
Catherine R. Olinger
Principal Investigator
University of Iowa