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

Phase 3

Not yet recruiting

• Conditions: Hemorrhage; Bleeding
• Interventions: Drug: Tranexamic Acid Injection [Cyklokapron]; Drug: Sodium chloride 0.9%

• Registration Number: NCT05464394
• Lead Sponsor: Franciscus Gasthuis

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-07-15
• Last Update Submitted: 2022-07-15
• Study First Posted: 2022-07-19
• Last Update Posted: 2022-07-19
• Study Start: 2022-09-01
• Primary Completion: 2024-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1524

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	Tranexamic Acid Injection [Cyklokapron]	1500mg Tranexamic acid
Placebo	Sodium chloride 0.9%	sodium chloride

Primary Outcome Measures

Name	Time	Method
re-intervention rate	30 days	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

Secondary Outcome Measures

Name	Time	Method
heart rate increase	1 day	heart rate increase postoperative
the use of haemostatic staple devices	peroperatively	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.
haemoglobin decrease	1 day	haemoglobin decrease postoperative
number of suspicion on haemorrhage for which extra haemoglobin monitoring	30 days	number of suspicion on haemorrhage for which extra haemoglobin monitoring
blood loss	peroperatively	blood loss in ml during surgery
the use of fibrin sealant	peroperatively	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.
number of suspicion on haemorrhage	30 days	number of suspicion on haemorrhage for which extra haemoglobin monitoring
VTE	30 days	VTE postoperative
complications rates	30 days	postoperative complications rates
length of hospital stay	30 days	length of hospital stay
duration of primary surgery	1 day	duration of primary surgery