An interventional study of Tranexamic acid and 0.9% NaCl (normal saline) in Posterior Lumbar Spinal Fusion Surgery, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by Yonsei University · Not applicable, Interventional, and Prevention
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.
Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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Exclusion Criteria:
Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia)
Drug: Tranexamic acid
placebo
Drug: 0.9% NaCl (normal saline)
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.
Also known as: glutamine
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).
base blood concentration of syndecan-1, heparan sulfate
preoperative baseline serum levels of syndecan-1 and heparan sulfate
Time frame: within 1 hour before surgery(base concentration)
blood concentration of syndecan-1, heparan sulfate at the end of the surgery
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 2 hours after surgery
blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery
Time frame: 2 hours after the end of surgery
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Yonsei University