Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO: A Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- incidence of ECMO related thrombotic events
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
argatroban group
Patients received argatroban for anticoagulation during V-V ECMO.
Intervention: Argatroban (Drug)
UFH group
Patients received UFH for anticoagulation during V-V ECMO.
Intervention: unfractionated heparin (Drug)
Outcomes
Primary Outcomes
incidence of ECMO related thrombotic events
Time Frame: 14 days
the incidence of ECMO related thrombotic events, such as membrane oxygenator or tube thrombosis.
Secondary Outcomes
No secondary outcomes reported
Investigators
Bing Sun
Professor
Beijing Chao Yang Hospital