Low Versus High Dose Tranexamic Acid in Adult Spinal Deformity Surgery: A Randomized, Blinded, Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Blood Loss
研究概览
简要总结
The purpose of this study is to evaluate two dosing protocols for tranexamic acid (TXA), an anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex, reconstructive spinal fusion surgeries.
详细描述
After consent is obtained and the patient is enrolled in the trial, patients will be assigned de-identified, unique identification (ID) numbers. Randomization of these IDs to either low or high dose TXA will occur via a computer generated random assignment. Given the variations that may exist in surgical technique (e.g. performance of osteotomies), stratified randomization will be performed by attending surgeon. Based upon the randomization, the pharmacy will prepare TXA for one of two intravenous dosing protocols:
- Low Dose (Standard of Care/Control): Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion
- High Dose (Study Group): Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion.
The surgeon, anesthesia team, and operating room staff will be blind to the concentration of TXA in the medications received. Treatments may be "unblinded" at the discretion of the surgeon and anesthesiologist, in cases of extreme blood loss. If additional anti-fibrinolytics are given, the change in dose will be recorded.
Post-operative care will be the same as any other patient and data collection will be information contained in the patient's medical record that is part of routine, standard of care.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (ages 18-75) scheduled to undergo long segment (greater than 8 motion segments) posterior spinal fusion with instrumentation (PSF) for adult scoliosis
排除标准
- •Patients with acquired defective color vision
- •Subarachnoid hemorrhage
- •Active intravascular clotting
- •Hypersensitivity to tranexamic acid or any of the ingredients
- •Patients who pre-donate autologous blood for intra- or post-operative use (Directed donor units are acceptable)
- •History of suspected blood disorders or abnormal coagulation laboratory results
- •Current anticoagulation therapy that cannot be interrupted
- •History of deep vein thrombosis (DVT)
- •Impaired renal function or creatinine clearance <60 ml/min
- •Pregnancy or women who are lactating/breastfeeding
- •Women on hormonal contraceptives
研究组 & 干预措施
High Dose/Study Group
Tranexamic Acid (Cyklokapron) Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
干预措施: Tranexamic Acid (Cyklokapron) (Drug)
Standard of Care/Control
Tranexamic Acid (Cyklokapron) Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion. The loading dose will be given to coincide with incision. The continuous infusion will be stopped at the conclusion of fascial layer closure.
干预措施: Tranexamic Acid (Cyklokapron) (Drug)
结局指标
主要结局
Blood Loss
时间窗: This outcome is measured during surgery, from exposure to wound closure, approximately 8 hours.
To compare the estimated blood loss in patients undergoing complex, reconstructive, spinal fusion surgeries receiving one of two dosing protocols for the anti-fibrinolytic, TXA. Estimated blood loss was calculated by suction canister volume minus intraoperative irrigation fluid plus blood content in sponges as estimated by weight for all cases.
次要结局
- Red Blood Cell Transfusions(Participants will be followed for the duration of their hospital stay measured from day of surgery to day of discharge from the hospital, approximately 7 days.)
- Number of Patients Sustaining Intraoperative or 90 Day Complications(Perioperative complications were defined as complications occurring within 90 days of surgery.)
研究者
Michael Kelly
Assistant Professor
Washington University School of Medicine