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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513570-22-00
Acronym
2022-031
Enrollment
1524
Registered
2024-05-23
Start date
2023-04-28
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Morbid obesity

Brief summary

Postoperative intervention due to haemorrhage (defined as: administration of packed red blood cells, surgical-, radiological-, or endoscopic intervention).

Detailed description

Use hemostatic staple devices, amount of hemostatic staples, use of fibrin sealant, the amount of blood loss peroperatively, decrease in hemoglobin postoperatively, increase in heart rate postoperatively, hematemesis and/or melena, rates of postoperative hemorrhage (i.e. hemorrhage for which extra hemoglobin monitoring and/or administration of TXA and/or reinterventions), rates of VTE, other complications, hospitalization time, painscore, side effects of TXA, duration of primary surgery.

Interventions

DRUGTRANEXAMIC ACID
DRUGSODIUM CHLORIDE

Sponsors

Sint Franciscus Vlietland Groep Stichting
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Postoperative intervention due to haemorrhage (defined as: administration of packed red blood cells, surgical-, radiological-, or endoscopic intervention).

Secondary

MeasureTime frame
Use hemostatic staple devices, amount of hemostatic staples, use of fibrin sealant, the amount of blood loss peroperatively, decrease in hemoglobin postoperatively, increase in heart rate postoperatively, hematemesis and/or melena, rates of postoperative hemorrhage (i.e. hemorrhage for which extra hemoglobin monitoring and/or administration of TXA and/or reinterventions), rates of VTE, other complications, hospitalization time, painscore, side effects of TXA, duration of primary surgery.

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026