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

Sponsor
Beijing Chao Yang Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04925167
Collaborator
(none)
174
Enrollment
1
Location
2
Arms
35.8
Anticipated Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
174 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO: A Randomized Controlled Study
Actual Study Start Date :
Jul 6, 2021
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: argatroban group

Patients received argatroban for anticoagulation during V-V ECMO.

Drug: Argatroban
Argatroban continuous intravenous injection maintained APTT at 1.5 times of baseline.
Other Names:
  • Novastan

    		•
    Active Comparator: UFH group

    Patients received UFH for anticoagulation during V-V ECMO.

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

    Outcome Measures

    Primary Outcome Measures

    1. incidence of ECMO related thrombotic events [14 days]

      the incidence of ECMO related thrombotic events, such as membrane oxygenator or tube thrombosis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bing Sun Beijing Beijing China 100020

    Sponsors and Collaborators

    • Beijing Chao Yang Hospital

    Investigators

    • Principal Investigator: Bing Sun, MD, Beijing Chao Yang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bing Sun, Professor, Beijing Chao Yang Hospital
    ClinicalTrials.gov Identifier:
    NCT04925167
    Other Study ID Numbers:
    • Argatroban in V-V ECMO
    First Posted:
    Jun 14, 2021
    Last Update Posted:
    Jul 9, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Respiratory Insufficiency
    Heparin
    Calcium heparin
    Argatroban

    Study Results

    No Results Posted as of Jul 9, 2021