Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO

Capital Medical University

Status: Completed

Conditions: Respiratory Failure

Treatments: Drug: unfractionated heparin; Drug: Argatroban

Study type: Interventional

Funder types: Other

Identifiers

NCT04925167

Argatroban in V-V ECMO

Details and patient eligibility

About

Unfractionated heparin is most common in the anticoagulation management of V-V ECMO. However, many side effects of unfractionated heparin, such as HIT, antithrombin deficiency, etc seriously affects the prognosis of patients. Argatroban is kind of direct thrombin inhibitors, which could be used used as an alternative anticoagulant of unfractionated heparin when HIT or antithrombin deficiency, etc. At present, there is no power enough evidence for the application of argatroban in V-V ECMO. This study aims to evaluat the safety and effectiveness of argatroban in the anticoagulation management of V-V ECMO compared with unfractionated heparin.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age older than 18 years old; received V-V ECMO because of sevever respiratory failure

Exclusion criteria

• anticoagulant contraindications; Confirmed or suspected, or previously diagnosed with heparin induced thrombocytopenia; Cerebral infarction or suspected patients; Patients with severe liver dysfunction; Allergic to heparin or argatroban; hemophilia; Unwilling or unable to complete the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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20 participants in 2 patient groups

argatroban group

Experimental group

Description:

Patients received argatroban for anticoagulation during V-V ECMO.

Treatment:

Drug: Argatroban

UFH group

Active Comparator group

Description:

Patients received UFH for anticoagulation during V-V ECMO.

Treatment:

Drug: unfractionated heparin