Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation

Xiaotong Hou154 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

154

Conditions

Extracorporeal Membrane Oxygenation Complication

Interventions

bivalirudinDRUG

bivalirudin as an anticoagulant

unfractionated heparinDRUG

unfractionated heparin as an anticoagulant

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years old 2. Accept VA-ECMO or VV-ECMO 3. the ECMO team believes that systemic anticoagulation is necessary and that APTT should be maintained at 40-60s. 4. sign the informed consent form Exclusion Criteria: 1. previous history of allergy to heparin or bivalirudin 2. previous diagnosis of heparin-induced thrombocytopenia. 3. the pre-random ECMO assistance time is more than 48 hours. 4. pregnant female 5. have participated in this study before. 6. the researchers believe that there are other factors that are not suitable to participate in this study.

Locations (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

RECRUITING