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Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery

2015年2月23日 更新者：Hospital Universitari Vall d'Hebron Research Institute

Current evidence regarding the efficacy and safety of perioperative administration of tranexamic acid for antifibrinolysis does not suffice to support its use in major spinal surgery.

OBJECTIVES: To evaluate the effectiveness of tranexamic acid for decreasing transfusion requirements and bleeding in this patient population. To evaluate the safety of this antifibrinolytic agent in the intraoperative and mid-term postoperative period.

METHODS: Multicenter, randomized, double-blind, placebo-controlled clinical trial with parallel groups. The main outcome measure is intraoperative and postoperative transfusion requirements; blood loss and safety will also be evaluated. Previous results in other types of surgery suggest that tranexamic acid reduces transfusion requirements and blood loss. Hence, the hypothesis of this study is that tranexamic acid will significantly reduce blood loss in comparison to a placebo in major spine surgery.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

96

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 西班牙
      • Barcelona、西班牙、08035
        • Hospital Vall d'Hebron de Barcelona
      • Barcelona、西班牙、08029
        • Hospital Clinic de Barcelona
    • Barcelona
      • Hospitalet de Llobregat、Barcelona、西班牙
        • Hospital de Bellvitge
    • Madrid
      • Getafe、Madrid、西班牙
        • Hospital de Getafe

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients ≥18 years old of both sexes
  • scheduled for complex spine surgery
  • ASA I-III
  • weighing more than 30 kg
  • body mass index <30 kg/m2
  • operated on in the participating hospitals
  • major spinal surgery
  • signed an informed consent form to be included in the study

Exclusion Criteria:

  • a history of allergy or hypersensitivity to the agent used
  • receiving medication that can interfere with coagulation (acetylsalicylic acid, oral anticoagulants, or antiplatelet agents)
  • a history of frequent bleeding
  • plasma creatinine values >1.5 mg/dL in the baseline analysis
  • platelet count less than 150,000/mm3 in the follow-up analysis
  • abnormal prothrombin time (INR >1.5) or partial thromboplastin time (INR >1.5)
  • a history of a thromboembolic episode before surgery
  • family history of thromboembolism
  • lack of consent to participate in the study
  • infectious disease, tumor or trauma of the spine as the reason for surgery
  • scheduled for surgery with an anterior and posterior surgical approach, whether sequential or on the same day

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

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
实验性的：tranexamic acid
tranexamic acid will be administered as a bolus (10-mg/kg dose ) or as a fast, 20-minute intravenous infusion before performing the incision at the start of surgery, followed by perfusion of 2 mg/kg/hour up to the time the surgical wound is closed at completion of surgery
药品：Tranexamic Acid
A 10-mg/kg dose of tranexamic acid will be administered as a bolus or as a fast, 20-minute intravenous infusion before performing the incision at the start of surgery, followed by perfusion of 2 mg/kg/hour up to the time the surgical wound is closed at completion of surgery.
安慰剂比较：placebo
The placebo will be administered according to the same regimen and infusion time as the medication in the study arm (bolus or 20-minute fast infusion before the incision at the beginning of surgery followed by perfusion of 2 mg/kg/hour until closure of the surgical wound at completion of surgery)
药品：fisiologic serum
The placebo will be administered according to the same regimen and infusion time as the medication in the study arm (bolus or 20-minute fast infusion before the incision at the beginning of surgery followed by perfusion of 2 mg/kg/hour until closure of the surgical wound at completion of surgery)

研究衡量的是什么？

主要结果指标

结果测量
大体时间
The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period
大体时间：7 days postoperative period
7 days postoperative period

次要结果测量

结果测量
措施说明
大体时间
Total blood loss: intraoperative and postoperative values
大体时间：48 hours postoperative
Intraoperative blood loss is evaluated by measuring the volume of suction aspirate and weighing the swabs with a precision digital scale. Postoperative blood loss is determined by recording the volume of blood collected through the suction drains at 24 and 48 hours.
48 hours postoperative
Adverse events in the perioperative period, immediate postoperative period, and at mid-term
大体时间：up to 6 weeks after the procedure
Adverse events in the perioperative period, immediate postoperative period, and at mid-term (up to 6 weeks after the procedure) will be recorded, with special emphasis on follow-up of thrombotic events and clinically suspected deep venous thrombosis, renal function, and visual abnormalities reported by the patient
up to 6 weeks after the procedure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hospital Universitari Vall d'Hebron Research Institute

合作者

Hospital Clinic of Barcelona
Hospital Universitari de Bellvitge
Hospital Vall d'Hebron
Hospital Universitario Getafe

调查人员

  • 学习椅：Maria J Colomina, MD Ph、Hospital Vall d'Hebron
  • 首席研究员：Misericordia Basora, MD Ph、Hospital Clinic of Barcelona
  • 首席研究员：Maylin Koo, MD Ph、Hospital Universitari de Bellvitge
  • 首席研究员：Javier Pizones, MD、Hospital de Getafe.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年9月1日

初级完成 (实际的)

2014年5月1日

研究完成 (实际的)

2014年5月1日

研究注册日期

首次提交

2010年6月2日

首先提交符合 QC 标准的

2010年6月2日

首次发布 (估计)

2010年6月3日

研究记录更新

最后更新发布 (估计)

2015年2月24日

上次提交的符合 QC 标准的更新

2015年2月23日

最后验证

2015年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TRANEX2009
  • 2008-006938-94 (EudraCT编号)

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.

出血的临床试验

Tranexamic Acid的临床试验

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条件

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膳食补充剂

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地点

3
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