Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery

NCT03085394 | Terminated Phase 3

• 1 other identifier: SMC-17-3846
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Morbid Obesity; Sleeve gastrectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Need for reintervention

  1 week

• Procedure change

  1 day

• Blood/blood product requirement

  1 week

Study Arms (2)

Treatment arm

ACTIVE COMPARATOR

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

Drug: tranexamic acid

Control Arm

PLACEBO COMPARATOR

Preoperative intravenous administration of 10ml normal saline.

Drug: Placebo

Interventions

tranexamic acid DRUG

Preoperative intravenous administration of 2 grams tranexamic acid in 10 ml saline

Also known as: Hexakapron

Treatment arm

Placebo DRUG

Preoperative intravenous administration of 10 ml saline

Control Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Morbid obesity
• Approved and scheduled for laparoscopic sleeve gastrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Postoperative Hemorrhage; Obesity, Morbid

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Bariatric and Metabolic Surgery

Study Record Dates

• First Submitted: March 19, 2017
• First Posted: March 21, 2017
• Study Start: September 1, 2017
• Primary Completion: November 21, 2022
• Study Completion: November 21, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

IL (1)