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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hemorrhage, Bleeding

Intervention / Treatment
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* Drug: Tranexamic Acid Injection [Cyklokapron]
* Drug: Sodium chloride 0.9%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid<br>1500mg Tranexamic acid | Drug: Tranexamic Acid Injection [Cyklokapron]<br>* 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.<br>|
| Placebo Comparator: Placebo<br>sodium chloride | Drug: Sodium chloride 0.9%<br>* 100 ml sodium chloride 0.9% will be administered in a time frame of 15-30 minutes<br>* Other names: Placebo;|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| length of hospital stay | length of hospital stay | 30 days | 
| duration of primary surgery | duration of primary surgery | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric bypass, Tranexamic acid