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

Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass to Reduce Haemorrhage (PATRY Study): a Randomised Controlled Trial

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 Overview

• Status: Not yet recruiting
• Conditions: Hemorrhage; Bleeding
• Intervention / Treatment: Drug: Tranexamic Acid Injection [Cyklokapron]; Drug: Sodium chloride 0.9%

• Study Type: Interventional
• Enrollment (Anticipated): 1524
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Judith WH Hart, MD; Phone Number: +31 010 - 461 6163; Email: j.hart@franciscus.nl
• Study Contact Backup: Name: Jan A Apers, MD; Phone Number: +31 010 - 461 6163; Email: j.apers@franciscus.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic acid; 1500mg Tranexamic acid	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.
Placebo Comparator: Placebo; sodium chloride	Drug: Sodium chloride 0.9%; 100 ml sodium chloride 0.9% will be administered in a time frame of 15-30 minutes; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of hospital stay	length of hospital stay	30 days
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.	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.	peroperatively
blood loss	blood loss in ml during surgery	peroperatively
haemoglobin decrease	haemoglobin decrease postoperative	1 day
heart rate increase	heart rate increase postoperative	1 day
number of suspicion on haemorrhage	number of suspicion on haemorrhage for which extra haemoglobin monitoring	30 days
number of suspicion on haemorrhage for which extra haemoglobin monitoring	number of suspicion on haemorrhage for which extra haemoglobin monitoring	30 days
VTE	VTE postoperative	30 days
complications rates	postoperative complications rates	30 days
duration of primary surgery	duration of primary surgery	1 day

Collaborators and Investigators

• Sponsor: Franciscus Gasthuis

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Tranexamic acid; Gastric bypass
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 2022-031; 2022-001384-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data Statement: The identified individual clinical trial participant-level data, protocols, and the statistical analysis plan will be available upon reasonable request at publication. These data will be available for researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. Proposals should be directed to j.apers@franciscus.nl, and to obtain access, data requestors will need a data access agreement.
• IPD Sharing Time Frame: Participant-level data, protocols, and the statistical analysis plan will be available upon reasonable request at publication. Within 1 year after the last follow-up.
• IPD Sharing Access Criteria: upon reasonable request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No