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the Use of Tranexamic Acid in Preventing Intraoperative and Postoperative Hemorrahge in Bariatric Surgery
Our study aims at evaluating the role of tranexamic acid in bariatric surgery since, The effect of conservative therapy using tranexamic acid for postoperative hemorrhage after bariatric surgery is still very much a novel technique. However,Intravenous tranexamic acid at the time of laparoscopic sleeve gastrectomy is associated with a significant reduction of post-operative bleeding with no observed differences in thromboembolic events or mortality.
Participants were randomized in a 1:1 ratio to receive tranexamic acid or placebo using a computer-generated block randomization sequence (block size = 4) prepared by an independent pharmacist. Allocation concealment was maintained with sequentially numbered, opaque, sealed envelopes. The pharmacist also prepared indistinguishable infusion bags containing either tranexamic acid (1 g diluted in 100 mL of 0.9% saline) or placebo (100 mL of 0.9% saline). The infusion was administered intravenously over 10-15 minutes immediately after induction of anesthesia and before skin incision, at a maximum rate of 100 mg per minute. Blinding was maintained for patients, anesthesiologists, scrub nurses, and all postoperative assessors, while the operating surgeon was necessarily unblinded, becoming aware of allocation only once the envelope was opened in the operating room. All analyses were performed according to the intention-to-treat principle.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
Cairo University
Giza, Manial, Egypt
Start Date
July 1, 2024
Primary Completion Date
July 1, 2025
Completion Date
July 1, 2025
Last Updated
September 22, 2025
132
ACTUAL participants
tranexamic acid (1 g diluted in 100 mL of 0.9% saline
DRUG
placebo (100 mL of 0.9% saline).
DRUG
Lead Sponsor
Cairo University
NCT06628531
NCT05695040
NCT02390973
Data Source & Attribution
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