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New Anticoagulation Strategies of VV-ECMO

Sponsor
Xiao Tang (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03497338
Collaborator
(none)
0
Enrollment
1
Location
35.9
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Effective and normative anticoagulation is one of the most important components of Extracorporeal membrane oxygenation (ECMO) management. Excessive anticoagulation may lead to hemorrhage, which is the most common and serious complication. Currently, the most common factors for monitoring anticoagulation of ECMO are the activated clotting time (ACT) and activated partial thromboplastin time (APTT). However, there is a lack of a unified understanding of the related monitoring measures, monitoring targets, and bleeding risk assessments, which have been chosen mainly because of experiences reported by various ECMO centers or the results of retrospective studies.Therefore, anticoagulation strategies need to be improved. Our research have found ECMO anticoagulation management should be transformed from monitoring only the APTT/activated clotting time (ACT) to considering the entire coagulation process. To maintain thrombosis ability and PLT function within normal ranges may help reduce hemorrhage rates and improve prognoses. This randomized controlled study aim to develop the safety and efficacy new anticoagulation strategies of VV-ECMO.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    the Efficacy and Safety of New Anticoagulation Strategies of Maintain Normal Clot Rate to Prevent Hemorrhage While VV-ECMO
    Actual Study Start Date :
    Apr 1, 2018
    Actual Primary Completion Date :
    Mar 30, 2021
    Actual Study Completion Date :
    Mar 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with hemorrhage events [4 weeks]

      1) fatal bleeding; 2) symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome; and/or 3. bleeding causing a drop in hemoglobin level by 20 g/L or more or requiring transfusion of two units of whole blood or red cells.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • age more than 18 years old, VV-ECMO is estimated more than 3 days
    Exclusion Criteria:
    • hemorrhage before VV-ECMO established, VV-ECMO more than 48 hours before admitted, VV-ECMO is estimated less than 3 days

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of respiratory and critical care medicine,Beijing Chao-yang Hospital Beijing Beijing China 100020

    Sponsors and Collaborators

    • Xiao Tang

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiao Tang, Principal Investigator, Beijing Chao Yang Hospital
    ClinicalTrials.gov Identifier:
    NCT03497338
    Other Study ID Numbers:
    • new anticoagulation of ECMO
    First Posted:
    Apr 13, 2018
    Last Update Posted:
    Apr 1, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hemorrhage

    Study Results

    No Results Posted as of Apr 1, 2021