Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery

Tranexamic Acid Clinical Trial

— PHORBBS  

Official title:

Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03085394
• Other study ID #: SMC-17-3846
• Status: Terminated
• Phase: Phase 3
• Start date: September 1, 2017
• Est. completion date: November 21, 2022

Study information

• Verified date: April 2023
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 152
• Est. completion date: November 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Intra-Operative Injury - Other
• Post Operative Hemorrhage
• Postoperative Hemorrhage
• Tranexamic Acid

Intervention

Drug:
• tranexamic acid
Preoperative intravenous administration of 2 grams tranexamic acid in 10 ml saline
• Placebo
Preoperative intravenous administration of 10 ml saline

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment efficiency (lowering/preventing clinically significant bleeding)	The efficiency of preoperative tranexamic acid administration in lowering/preventing clinically significant bleeding.	1 week
Primary	Treatment safety (administering tranexamic acid preoperatively without promoting thromboembolic events)	The safety of administering tranexamic acid preoperatively without promoting thromboembolic events	2 months
Secondary	Need for reintervention	The proportion of patients requiring invasive intervention (percutaneous/operative) due to bleeding	1 week
Secondary	Procedure change	The proportion of patients requiring alteration of intended procedure due to bleeding.	1 day
Secondary	Blood/blood product requirement	The usage of blood/blood products after surgery	1 week