Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery

Phase 3

Terminated

• Conditions: Intra-Operative Injury - Other; Post Operative Hemorrhage; Tranexamic Acid
• Interventions: Drug: Placebo; Drug: tranexamic acid

• Registration Number: NCT03085394
• Lead Sponsor: Sheba Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2017-03-19
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-21
• Study Start: 2017-09-01
• Primary Completion: 2022-11-21
• Study Completion: 2022-11-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• Morbid obesity
• Approved and scheduled for laparoscopic sleeve gastrectomy

Exclusion Criteria

• Previous bariatric surgery
• Platelet count under 100,000
• Concurrent anticoagulation treatment
• Previous venous/atrerial thromboembolic event
• Known allergy to tranexamic acid
• History of heparin induced thrombocytopenia
• Oral contraceptive use
• Female hormonal replacement therapy
• Active thromboembolic state
• Genetic hypercoagulable state

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Placebo	Preoperative intravenous administration of 10ml normal saline.
Treatment arm	tranexamic acid	Preoperative intravenous administration of 2g tranexamic acid in 10ml fluid.

Primary Outcome Measures

Name	Time	Method
Treatment efficiency (lowering/preventing clinically significant bleeding)	1 week	The efficiency of preoperative tranexamic acid administration in lowering/preventing clinically significant bleeding.
Treatment safety (administering tranexamic acid preoperatively without promoting thromboembolic events)	2 months	The safety of administering tranexamic acid preoperatively without promoting thromboembolic events

Secondary Outcome Measures

Name	Time	Method
Need for reintervention	1 week	The proportion of patients requiring invasive intervention (percutaneous/operative) due to bleeding
Procedure change	1 day	The proportion of patients requiring alteration of intended procedure due to bleeding.
Blood/blood product requirement	1 week	The usage of blood/blood products after surgery

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel