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

Respiratory Failure Clinical Trial

Official title:

Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04925167
• Other study ID #: Argatroban in V-V ECMO
• Status: Completed
• Phase: N/A
• Start date: July 6, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Drug:
• Argatroban
Argatroban continuous intravenous injection maintained APTT at 1.5 times of baseline.
• unfractionated heparin
unfractionated heparin continuous intravenous injection maintained APTT at 1.5 times of baseline.

Locations

Country	Name	City	State
China	Bing Sun	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of ECMO related thrombotic events	the incidence of ECMO related thrombotic events, such as membrane oxygenator or tube thrombosis.	14 days