Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery
研究概览
详细说明
This will be a multicenter, randomized, double-blind, parallel group study comparing tranexamic acid (test) to placebo (control) for reduction of perioperative blood loss after complex spinal fusion surgery (defined as T2 to Pelvis/Sacrum and greater than 4 Functional Spinal Units (4 discs/motion segments=5 Vertebral segments)). In addition to test and control treatments, all patients undergoing spinal fusion surgery will receive anesthesia and standard of care for blood loss including colloid/crystalloid fluid replacement and packed red cells, if necessary, according to a common multi-institutional protocol. Anesthesia will keep the mean arterial pressure as low as safe for the patient during exposure of surgery (estimated at 60-80 MAP). Patients will be randomized to receive either 30 mg/kg tranexamic acid as a one hour infusion (3 mL/kg) loading dose prior to start of procedure and as an infusion at 3 mg/kg/h (0.3 mL/kg/h) of tranexamic acid throughout the surgery in the test group; or, a one hour infusion at 3 mL/kg of 0.9% saline prior to start of the procedure and an infusion of 0.9% saline at 0.3 mL/kg/h in the control group. The maximum total dose will be 50 mg/kg.
The active phase of the study will be until discharge postoperatively for efficacy measurements and at 6 weeks for safety follow-up. The randomization will be open only to the statistician generating the randomization sequence. All PI(s), study conduct and monitoring staff, as well as the subjects will be completely blinded to the treatments except in the case of emergency.
The study will be terminated if ≥5/12 or 10/36 patients enrolled in the study are diagnosed with treatment related serious adverse events.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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California
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Long Beach、California、美国、90806
- Memorial Orthopaedic Surgery Group
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Los Angeles、California、美国、90048
- Cedars-Sinai Medical Center
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Illinois
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Chicago、Illinois、美国、60612
- Rush University Medical Center - Division of Spine Surgery
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New York
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New York、New York、美国、10016
- Spine Care Orthopedics - NYU Lagone Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- All adult patients (Male or Female) over age eighteen (>18) electively undergoing complex spinal fusion surgery (defined as T2 to Pelvis/Sacrum and greater than 4 Functional Spinal Units (4 discs/motion segments=5 Vertebral segments).
- Female subjects of childbearing potential with a negative serum (beta human chorionic gonadotropin [HCG]) pregnancy test at screening and urine pregnancy test at each admission; who are not breastfeeding; do not plan to become pregnant during the course of the study; and agree to use an approved method of birth control, such as condoms, foams, jellies, diaphragm, intrauterine device, sexual abstinence for at least 3 months prior to study
- Able to provide written informed consent after risks and benefits of the study have been explained
- Able to communicate effectively with study personnel.
Exclusion Criteria:
- History or presence of any clinically significant (based on the Investigator's judgment) cardiovascular, respiratory, metabolic, hepatic, gastrointestinal, renal, hematological, dermatological, neurological, or psychiatric disease or condition preventing the use of tranexamic acid
- History of renal failure or elevated creatinine above 1.4
- Any diagnosis of spinal tumor or intradural pathology
- Diagnosis of ankylosing spondylitis
- History or presence of acquired disturbance of color vision
- History of seizures
- History of thromboembolic event (DVT or PE) within the past year
- Current use of anticoagulant medications or past medical history leading to an abnormal coagulation profile preoperatively
- Subjects diagnosed with fibrinolytic disorders requiring intra-operative antifibrinolytic treatment; hematological disease (thromboembolic events, hemoglobinopathy, coagulopathy, or hemolytic disease)
- Significant drug sensitivity or significant allergic reaction to any drug, including tranexamic acid, based on the Investigator's judgment
- A subject who has donated or lost 450 mL or more blood volume (including plasmaphoresis) or had a transfusion of any product within 3 months prior to the initial study drug administration
- Pre-operative anemia (hb <110 in females, Hb <120 in males)
- Any subject that chooses to refuse blood products for ethical or religious purposes (Jehovah's Witness)
- Current participation in a drug or other investigational research study or participation within 30 days prior to the initial study drug administration
- A subject who may not be able to comply with the safety monitoring requirements of this clinical trial or is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- Intraoperative cardiovascular, pulmonary, orthopedic, or anesthetic complication such as myocardial infarction, intraoperative fracture, vasopressor support or emergent intubation.
- Female patients who are using combination hormonal contraception.
- Patients with history of subarachnoid hemorrhage.
- Patients with serum creatinine above upper limit of normal (ULN).
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Sodium Chloride 0.9%
Sodium Chloride 0.9% infused at 3 mL/kg over one hour followed by continuous infusion at 0.3 mL/kg for maximum infusion volume of 5 mL/kg
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Inactive ingredient mixture for injection without drug, intravenous infusion bags containing normal saline, manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot.
其他名称：
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实验性的：Tranexamic Acid 10 mg/mL
Tranexamic Acid 10 mg/mL infused at 3 mL/kg over one hour followed by continuous infusion at 0.3 mL/kg for maximum infusion volume of 5 mL/kg
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Tranexamic Acid Intravenous Infusion Bags (10 mg/mL), manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Total Blood Loss
大体时间：From time of surgery until discharge
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The Total Blood Loss will be estimated based on the hemoglobin content of the blood prior to surgery (mg/dL) and at each of the desired post-surgery time-points (mg/dL).
Blood samples for hemoglobin measurement will be collected prior to start of procedure, at the end of the procedure, at 24 h, and every 24 h thereafter until discharge and removal two subfascial drains.
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From time of surgery until discharge
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Incidence of Autologous or Allogenic Blood Transfusion
大体时间：From time of surgery until discharge
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Number of Units of autologous transfusion and allogenic transfusion
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From time of surgery until discharge
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Total Measured Blood Loss
大体时间：From time of surgery up to 24 hours after surgery
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Estimated as 3x cell saver
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From time of surgery up to 24 hours after surgery
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Number of Patients With Symptomatic Anemia Precipitated Transfusion
大体时间：Until discharge
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Number of patients with symptomatic anemia precipitated transfusion in each group
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Until discharge
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Number of Patients With Adverse Events Related to Tranexamic Acid
大体时间：up to 6 weeks
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Number of patients with adverse events related to tranexamic acid in each group
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up to 6 weeks
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合作者和调查者
调查人员
- 首席研究员：Neel Anand, MD、Cedars-Sinai Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Sodium Chloride 0.9% Inj的临床试验
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Ho Cheol Shin, M.D., Ph.D.Green Cross Corporation; Ajou University School of Medicine; Symyoo完全的