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临床试验/NCT01643135
NCT01643135已完成4 期

Reduction Perioperative Bleeding in Laminectomy With Instrumentation or More Than or Equal to 3 Levels Laminectomy: The Comparison Between Placebo, and Double Doses of Tranexamic Acid (15 mg/kg and 15 mg/kg)

Mahidol University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
78
试验地点
1
主要终点
perioperative blood loss

研究概览

简要总结

Tranexamic acid has benn widely used to reduce perioperative bleeding in several operations such as cardiac surgery, liver transplant and joint arthroplasty with good results. Few studies in laminectomy had conflicting results and varying in doses. The objective is to compare perioperative bleeding in major laminectomy between patients receive doubles doses of tranexamic acids (15 mg/kg and 15 mg/kg) with who receive pacebo (0.9% NaCl).

详细描述

78 patients undergoing major laminectomy (with instrumentation or equal or more than 3 levels laminectomy) will be enrolled. We exclude patients who age over 65, anemia, allergy to tranexamic acid, history of deep vein thormbosis (DVT), ischemic heart disease (IHD), pulmonary embolism (PE), strokes, liver disease, chronic kidney disease with creatinine >2.0 mg/dl, and coagulopathy. After randomization, before induction and 3 hour after the first dose, patients will receive study drug or placebo intravenously. The standard anesthesia and monitoring will be tha same for all of the patients. Perioperative mild hypotensive technique will be used with the mean arterial pressure more than 60 mmHg and nearly the end, the blood pressure will be back to normal for the bleeding check. Hematocrit will be monitored at the begining and every two hours. Blood will be given if the hematocrit is below 30%. The perioperative fluid will be managed by anesthesiologist who will not know the patients' groups. The next morning, the hematocrit and blood creatinine will be checked and if the hematocrit is lower than 30%, blood will be given. Perioperative blood loss, total fluid and blood transfusion within 24 hours will be recorded. If there are any suspected symptoms and signs of DVT, angina, CHF, PE, strokes or other complications, the necessory investigations will be done for the definite dignosis and the appropriate treatment will be started immediately.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • has laminectomy with instrumentation or equal or more than 3 levels laminectomy
  • age 18-65 years
  • elective operation

排除标准

  • allergy to tranexamic acid
  • anemia (Hb<12 g/dl in female or Hb<13 g/dl in male)
  • history of CVT, IHD, PE, strokes
  • liver disease
  • chronic kidney disease with creatinie>2.0 mg/dl
  • receive anticoagulant or coagulopathy

研究组 & 干预措施

tranexamic acid

Active Comparator

Tranexamic acid (15 mg/kg in 0.9% NaCl and the total volume is 100 ml) will given before induction and the second dose(15 mg/kg in 0.9% NaCl and the total volume is 100 ml) will be given at 3 hours after the first dose.

干预措施: tranexamic acid (Drug)

0.9% NaCl

Placebo Comparator

0.9% NaCl 100 ml will be given as a placebo before induction and 3 hours after the first dose

干预措施: 0.9% NaCl (Drug)

结局指标

主要结局

perioperative blood loss

时间窗: 24 hours

Intraoperative and postoperative blood loss will be measured by from swab, suction and vaccum drainage

次要结局

  • perioperative blood transfusion(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manee Raksakietisak

Associate professor

Mahidol University

研究点 (1)

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