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

Franciscus Gasthuis1,524 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

1,524

Conditions

Hemorrhage Bleeding

Interventions

Tranexamic Acid Injection [Cyklokapron]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.

Sodium chloride 0.9%DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

re-intervention rate

To compare the re-intervention rate due to haemorrhage within 30 days postoperative, after peroperative administration of TXA versus placebo in patients receiving a RYGB or OAGB

Time frame: 30 days

Secondary Outcomes

the use of haemostatic staple devices

measurement (yes/no). Peroperatively, only on active bleeding a heamostatic staple device will be used. If there is no bleeding no haemostatic staple device will be used.

Time frame: peroperatively

the use of fibrin sealant

measurement (yes/no). Peroperatively, if the staple line is not actively bleeding but is oozing, fibrin sealant is used. If there is no oozing, fibrin sealant is not used.

Time frame: peroperatively

blood loss

blood loss in ml during surgery

Time frame: peroperatively

haemoglobin decrease

haemoglobin decrease postoperative

Time frame: 1 day

heart rate increase

heart rate increase postoperative

Time frame: 1 day

number of suspicion on haemorrhage

number of suspicion on haemorrhage for which extra haemoglobin monitoring

Time frame: 30 days

number of suspicion on haemorrhage for which extra haemoglobin monitoring

Central Contacts

Judith WH Hart, MD

CONTACT

010 - 461 6163 j.hart@franciscus.nl

Jan A Apers, MD

CONTACT

010 - 461 6163 j.apers@franciscus.nl

Data from ClinicalTrials.gov

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