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OpenTrials
Completed

NCT Number: NCT03697681

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

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.

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Key information

Conditions

Posterior Lumbar Spinal Fusion Surgery

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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.

Other names: glutamine

0.9% NaCl (normal saline)

Drug

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).

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2018
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.