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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03497338
Other study ID # new anticoagulation of ECMO
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date March 30, 2021

Study information

Verified date March 2021
Source Beijing Chao Yang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 30, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Department of respiratory and critical care medicine,Beijing Chao-yang Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Xiao Tang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants with hemorrhage events 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. 4 weeks
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