Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery

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

Detailed Description
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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.

Official Title
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Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery

Conditions
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Intra-Operative Injury - Other, Post Operative Hemorrhage, Tranexamic Acid

Intervention / Treatment
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* Drug: tranexamic acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment arm<br>Preoperative intravenous administration of 2g tranexamic acid in 10ml fluid. | Drug: tranexamic acid<br>* Preoperative intravenous administration of 2 grams tranexamic acid in 10 ml saline<br>* Other names: Hexakapron;|
| Placebo Comparator: Control Arm<br>Preoperative intravenous administration of 10ml normal saline. | Drug: Placebo<br>* Preoperative intravenous administration of 10 ml saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment efficiency (lowering/preventing clinically significant bleeding) | The efficiency of preoperative tranexamic acid administration in lowering/preventing clinically significant bleeding. | 1 week | 
| Treatment safety (administering tranexamic acid preoperatively without promoting thromboembolic events) | The safety of administering tranexamic acid preoperatively without promoting thromboembolic events | 2 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbid Obesity, Sleeve gastrectomy