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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1524 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemorrhage Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Tranexamic acid

1500mg Tranexamic acid

Group Type EXPERIMENTAL

Tranexamic Acid Injection [Cyklokapron]

Intervention Type DRUG

A set dose of 1500 mg will be used, based on the study population with morbid obesity. It will be administered intravenous dissolved in 100 ml sodium chloride 0.9% in a time frame of 15-30 minutes, with a maximum of 100 mg/min.

Placebo

sodium chloride

Group Type PLACEBO_COMPARATOR

Sodium chloride 0.9%

Intervention Type DRUG

100 ml sodium chloride 0.9% will be administered in a time frame of 15-30 minutes

Interventions

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Tranexamic Acid Injection [Cyklokapron]

A set dose of 1500 mg will be used, based on the study population with morbid obesity. It will be administered intravenous dissolved in 100 ml sodium chloride 0.9% in a time frame of 15-30 minutes, with a maximum of 100 mg/min.

Intervention Type DRUG

Sodium chloride 0.9%

100 ml sodium chloride 0.9% will be administered in a time frame of 15-30 minutes

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No