NCT06275555

Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation

Efficacy and Safety of Bivalirudin Versus Heparin in Anticoagulant Therapy of ECMO: a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Xiaotong Hou · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacy and safety of bivalirudin in anticoagulation therapy in patients with extracorporeal membrane oxygenation (ECMO) compared with unfractionated heparin.

Detailed description

Patients with ECMO who needed systemic anticoagulation were randomly divided into bivalirudin group and unfractionated heparin group;the efficacy of bivalirudin in ECMO anticoagulation was evaluated by comparing the percentage of time within the target anticoagulation level and the incidence of thrombotic complications between the two groups during ECMO; and the safety of bivalirudin in ECMO anticoagulation was evaluated by comparing bleeding complications, blood product infusion and the incidence of acute renal failure between the two groups.

Conditions

• Extracorporeal Membrane Oxygenation Complication

Interventions

Type	Name	Description
DRUG	bivalirudin	bivalirudin as an anticoagulant
DRUG	unfractionated heparin	unfractionated heparin as an anticoagulant

Timeline

• Start date: 2024-06-03
• Primary completion: 2026-12-31
• Completion: 2027-03-01
• First posted: 2024-02-23
• Last updated: 2026-04-06

Locations

1 site across 1 country: China