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Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery (PHORBBS)

S

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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