Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery (PHORBBS)

Sheba Medical Center

Status and phase: Terminated; Phase 3

Conditions: Post Operative Hemorrhage; Intra-Operative Injury - Other; Tranexamic Acid

Treatments: Drug: tranexamic acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03085394

SMC-17-3846

Details and patient eligibility

About

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

Full 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.

Enrollment: 152 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

152 participants in 2 patient groups, including a placebo group

Treatment arm

Active Comparator group

Description:

Preoperative intravenous administration of 2g tranexamic acid in 10ml fluid.

Treatment:

Drug: tranexamic acid

Control Arm

Placebo Comparator group

Description:

Preoperative intravenous administration of 10ml normal saline.

Treatment:

Drug: Placebo