Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass (PATRY)

Franciscus Gasthuis

Status and phase: Not yet enrolling; Phase 3

Conditions: Hemorrhage; Bleeding

Treatments: Drug: Sodium chloride 0.9%; Drug: Tranexamic Acid Injection [Cyklokapron]

Study type: Interventional

Funder types: Other

Identifiers

NCT05464394

2022-031

2022-001384-27 (EudraCT Number)

Details and patient eligibility

About

The incidence of bleeding after metabolic surgery seems to increase. The administration of a drug (tranexamic acid) that can reduce bleeding could possibly also reduce bleeding after metabolic surgery.

Objective: This study aims to determine whether administration of tranexamic acid before surgery can reduce postoperative bleeding in patients undergoing gastric bypass.

Enrollment: 1,524 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary metabolic procedure;
• Gastric bypass: Roux-en-Y gastric bypass or One-anastomoses gastric bypass;
• ≥18 years;
• Good command of the Dutch or English language.

Exclusion criteria

• Patients unwilling to give informed consent;
• Patients with a medical history of bleeding or VTE (defined as, pulmonary embolism (PE) or deep vein thrombosis (DVT));
• Patients who use anticoagulants;
• Arterial bleeding or (iatrogenic) bleeding during the procedure coming from surrounding organs or vascular structures such as the liver or the spleen.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,524 participants in 2 patient groups, including a placebo group

Tranexamic acid

Experimental group

Description:

1500mg Tranexamic acid

Treatment:

Drug: Tranexamic Acid Injection [Cyklokapron]

Placebo

Placebo Comparator group

Description:

sodium chloride

Treatment:

Drug: Sodium chloride 0.9%