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

Bleeding Clinical Trial

— PATRY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05464394
• Other study ID #: 2022-031
• Secondary ID: 2022-001384-27
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 1, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: July 2022
• Source: Franciscus Gasthuis
• Contact: Judith WH Hart, MD
• Phone: 010 - 461 6163
• Email: j.hart[@]franciscus.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1524
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Franciscus Gasthuis

Outcome

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