Intra-Operative Injury - Other, Post Operative Hemorrhage, Tranexamic Acid
Conditions
Keywords
Morbid Obesity, Sleeve gastrectomy
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.
Interventions
DRUGtranexamic acid
Preoperative intravenous administration of 2 grams tranexamic acid in 10 ml saline
DRUGPlacebo
Preoperative intravenous administration of 10 ml saline
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Israel
Outcome results
None listed