Peroperative Administration of Tranexamic Acid in Sleeve gastrectomy (PATAS) to reduce hemorrhage rates
Phase 3
Completed
- Conditions
- 10003018hemorrhageSleeve gastrectomy1006447710017998
- Registration Number
- NL-OMON47960
- Lead Sponsor
- Sint Franciscus Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
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>