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NCT03085394 Clinical Trial

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
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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