Peroperative Administration of Tranexamic Acid in Sleeve gastrectomy (PATAS) to reduce hemorrhage rates

Phase 3

Completed

• Conditions: 10003018; hemorrhage; Sleeve gastrectomy; 10064477; 10017998

• Registration Number: NL-OMON47960
• Lead Sponsor: Sint Franciscus Gasthuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-01-12
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 112

Inclusion Criteria

Primary laparoscopic sleeve gastrectomy; 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 and patients who use therapeutic anticoagulants. Patients will
also be excluded in case of peroperative arterial bleeding or (iatrogenic)
bleeding coming from surrounding organs or vascular structures

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measures are peroperative use of hemostatic clips, the decrease<br /><br>in hemoglobin after the procedure and rates of postoperative hemorrhage (i.e.<br /><br>hemorrhage needing administration of packed cells or a surgical or radiological<br /><br>re-intervention). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are rates of deep venous thrombosis (DVT) and<br /><br>pulmonary embolism (PE). </p><br>