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

NCT05464394 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1524

Last updated 2022-07-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

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.

DRUG

Sodium chloride 0.9%

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

Sponsors & Collaborators

  • Franciscus Gasthuis

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-09-01
Completion
2025-09-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05464394 on ClinicalTrials.gov