Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
152
Preoperative intravenous administration of 2 grams tranexamic acid in 10 ml saline
Preoperative intravenous administration of 10 ml saline
Sheba Medical Center
Tel Litwinsky, Israel
Treatment efficiency (lowering/preventing clinically significant bleeding)
The efficiency of preoperative tranexamic acid administration in lowering/preventing clinically significant bleeding.
Time frame: 1 week
Treatment safety (administering tranexamic acid preoperatively without promoting thromboembolic events)
The safety of administering tranexamic acid preoperatively without promoting thromboembolic events
Time frame: 2 months
Need for reintervention
The proportion of patients requiring invasive intervention (percutaneous/operative) due to bleeding
Time frame: 1 week
Procedure change
The proportion of patients requiring alteration of intended procedure due to bleeding.
Time frame: 1 day
Blood/blood product requirement
The usage of blood/blood products after surgery
Time frame: 1 week
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