Peroperative Administration of Tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce hemorrhage rates (PATRY study): a randomized controlled trial
Phase 3
Recruiting
- Conditions
- Gastric bypasshemorraghe100644771000301810017998
- Registration Number
- NL-OMON53532
- Lead Sponsor
- Franciscus Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1524
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria: Primary metabolic procedure; >=18 years; good command
of the Dutch or English language.
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study: 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)) 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 such as the liver or the spleen.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measure is postoperative reintervention (administration of<br /><br>packed red blood cells or, surgical-, radiological-, or endoscopic<br /><br>intervention). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures are the use of haemostatic staple devices and fibrin<br /><br>sealant preoperatively, postoperatively decrease in haemoglobin, increase in<br /><br>heart rate, rates of suspicions of postoperative haemorrhage (i.e. haemorrhage<br /><br>for which extra haemoglobin monitoring and administration of TXA) and rates of<br /><br>VTE, other complications, hospitalization time.</p><br>