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Peroperative Administration of Tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce hemorrhage rates (PATRY study): a randomized controlled trial

Peroperative Administration of Tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce hemorrhage rates (PATRY study): a randomized controlled trial - PATRY

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53532
Enrollment
1524
Registered
2023-02-07
Start date
2023-04-28
Completion date
Unknown
Last updated
2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric bypass hemorraghe

Interventions

Patients are randomised between 2 groups: 1) Single dose of 1500 mg TXA, and 2) Placebo infusion, both to be administered during induction of the procedure by anaesthesiologist.

Sponsors

Franciscus Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Primary outcome measure is postoperative reintervention (administration of packed red blood cells or, surgical-, radiological-, or endoscopic intervention).

Secondary

MeasureTime frame
Secondary outcome measures are the use of haemostatic staple devices and fibrin sealant preoperatively, postoperatively decrease in haemoglobin, increase in heart rate, rates of suspicions of postoperative haemorrhage (i.e. haemorrhage for which extra haemoglobin monitoring and administration of TXA) and rates of VTE, other complications, hospitalization time.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)