Protective Effect of Tranexamic Acid on Shedding of the Endothelial Glycocalyx in Patients Undergoing Spinal Fusion Surgery

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追踪信息

首次提交日期 ^ICMJE

October 1, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

October 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

base blood concentration of syndecan-1, heparan sulfate[ Time Frame: within 1 hour before surgery(base concentration) ]

preoperative baseline serum levels of syndecan-1 and heparan sulfate

blood concentration of syndecan-1, heparan sulfate at the end of the surgery[ Time Frame: within 5 minutes after the end of surgery (when thd surgical drape is removed) ]

blood concentration of syndecan-1, heparan sulfate at the end of the surgery

blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery[ Time Frame: 2 hours after the end of surgery ]

blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

[ Time Frame: ]

描述性信息

简略标题 ^ICMJE

Protective Effect of Tranexamic Acid on Shedding of the Endothelial Glycocalyx in Patients Undergoing Spinal Fusion Surgery

正式标题 ^ICMJE

Protective Effect of Tranexamic Acid on Shedding of the Endothelial Glycocalyx in Patients Undergoing Spinal Fusion Surgery

简要概况

The aim of this study was to determine whether the administration of tranexamic acid in patients undergoing lumbar spinal fusion surgery can inhibit damage in endothelial glycocalyx layer. As a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the changes in concentrations of serum syndecan-1 and heparan sulfate before and after surgery.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述: A Randomized, Double-Blinded, Placebo-Controlled Trial
盲法: Interventional
盲法描述:triple blinded (Participant, Care Provider, investigator)
主要目的: Prevention

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Tranexamic acid
Intravenous infusion of Tranexamic acid(mixed with normal saline) at the dose of 10mg/kg(body weight) for 20 min after induction of anesthesia and then administration another 1mg/kg/hr(body weight) of Tranexamic acid(mixed with normal saline) until the end of the operation.
Drug: 0.9% NaCl (normal saline)
The same amount of normal saline solution without the addition of tranexamic acid is administered in the same manner as the experimental group(Tranexamic acid intervention group).

研究工具

Experimental: Glutamine
Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia)
Placebo Comparator: Placebo
placebo

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

128

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

October 2020

预计主要完成日期

October 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Adult patients with between 30 and 80 years scheduled for posterior lumbar spinal fusion surgery. Exclusion Criteria: - emergency surgery - patients unable to make their own decisions, illiterate, foreigners - Allergy / hypersensitivity to Tranexamic acid - Current or past history or thrombosis / thromboembolism - patients who are taking oral contraceptives - Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less) - Patients receiving anticoagulants - pregnant and lactating women

性别

参与研究的性别:

All

年龄

最小年龄：30 Years ，最大年龄：80 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

Korea, Republic of

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

Undecided

责任方

，

研究赞助商 ^ICMJE

Yonsei University

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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