Posterior Lumbar Spinal Fusion Surgery
Conditions
Brief summary
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.
Interventions
DRUGTranexamic 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.
DRUG0.9% 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).
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
triple blinded (Participant, Care Provider, investigator)
Intervention model description
A Randomized, Double-Blinded, Placebo-Controlled Trial
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| base blood concentration of syndecan-1, heparan sulfate | 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 | 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 | 2 hours after the end of surgery | blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery |
Countries
South Korea
Outcome results
None listed