NCT03085394

Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied.

Detailed description

Patients scheduled for primary laparoscopic sleeve gastrectomy for the treatment of morbid obesity will be assigned to receive tranexamic acid vs. placebo before surgery. Intraoperative bleeding will be scored, as well as postoperative bleeding and blood or blood-product requirements. POstoperative venous thromboembolic events will be recorded up to 2 months following surgery.

Conditions

• Intra-Operative Injury - Other
• Post Operative Hemorrhage
• Tranexamic Acid

Interventions

Type	Name	Description
DRUG	tranexamic acid	Preoperative intravenous administration of 2 grams tranexamic acid in 10 ml saline
DRUG	Placebo	Preoperative intravenous administration of 10 ml saline

Timeline

• Start date: 2017-09-01
• Primary completion: 2022-11-21
• Completion: 2022-11-21
• First posted: 2017-03-21
• Last updated: 2023-04-19

Locations

1 site across 1 country: Israel