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

Yonsei University

Status: Completed

Conditions: Posterior Lumbar Spinal Fusion Surgery

Treatments: Drug: 0.9% NaCl (normal saline); Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03697681

4-2018-0754

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 2 patient groups, including a placebo group

Glutamine

Experimental group

Description:

Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia)

Treatment:

Drug: Tranexamic acid

Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: 0.9% NaCl (normal saline)