Peroperative Administration of Tranexamic acid in gastric bypass to reduce haemorrhage in patients with morbid obesity

Phase 3

Recruiting

Conditions: Morbid obesity

Interventions: Drug: Tranexamic Acid Injection [Cyklokapron]
Drug: Sodium chloride 0.9%

Registration Number: 2024-513570-22-00

Lead Sponsor: Sint Franciscus Vlietland Groep Stichting

Brief Summary: This trial aims to investigate whether peroperative administration of TXA reduces haemorrhage rates in patients who undergo gastric bypass surgery.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

Target Recruitment: 1524

Inclusion Criteria

Patients aged 18 years or older, eligible for bariatric surgery according to the IFSO guidelines and undergoing a laparoscopic (Roux-en-Y or one-anastomosis) gastric bypass.

Exclusion Criteria

Patients unwilling to give informed consent, patients with a medical history of bleeding or venous thromboembolism and patients that use anticoagulants will be excluded.

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
Postoperative intervention due to haemorrhage (defined as: administration of packed red blood cells, surgical-, radiological-, or endoscopic intervention).		Postoperative intervention due to haemorrhage (defined as: administration of packed red blood cells, surgical-, radiological-, or endoscopic intervention).

Secondary Outcome Measures

Name	Time	Method
Use hemostatic staple devices, amount of hemostatic staples, use of fibrin sealant, the amount of blood loss peroperatively, decrease in hemoglobin postoperatively, increase in heart rate postoperatively, hematemesis and/or melena, rates of postoperative hemorrhage (i.e. hemorrhage for which extra hemoglobin monitoring and/or administration of TXA and/or reinterventions), rates of VTE, other complications, hospitalization time, painscore, side effects of TXA, duration of primary surgery.		Use hemostatic staple devices, amount of hemostatic staples, use of fibrin sealant, the amount of blood loss peroperatively, decrease in hemoglobin postoperatively, increase in heart rate postoperatively, hematemesis and/or melena, rates of postoperative hemorrhage (i.e. hemorrhage for which extra hemoglobin monitoring and/or administration of TXA and/or reinterventions), rates of VTE, other complications, hospitalization time, painscore, side effects of TXA, duration of primary surgery.

Trial Locations

Locations (6): Rijnstate Ziekenhuis Stichting
🇳🇱
Arnhem, Netherlands
Elisabeth-Tweesteden Ziekenhuis
🇳🇱
Tilburg, Netherlands
Stichting OLVG
🇳🇱
Amsterdam, Netherlands
Ziekenhuisgroep Twente Stichting
🇳🇱
Almelo, Netherlands
Sint Franciscus Vlietland Groep Stichting
🇳🇱
Rotterdam, Netherlands
Zuyderland Medisch Centrum Stichting
🇳🇱
Heerlen, Netherlands
Rijnstate Ziekenhuis Stichting
🇳🇱Arnhem, Netherlands
Eric Hazebroek
Site contact
+31880058888
EHazebroek@Rijnstate.nl