Protective Effect of Tranexamic Acid on Shedding of the Endothelial Glycocalyx in Patients Undergoing Spinal Fusion Surgery
NCT ID: NCT03697681
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2018-10-16
2020-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Glutamine
Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia)
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.
Placebo
placebo
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).
Interventions
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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.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
30 Years
80 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Other Identifiers
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4-2018-0754
Identifier Type: -
Identifier Source: org_study_id
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