New Anticoagulation Strategies of VV-ECMO

Hemorrhage Clinical Trial

Official title:

the Efficacy and Safety of New Anticoagulation Strategies of Maintain Normal Clot Rate to Prevent Hemorrhage While VV-ECMO

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03497338
• Other study ID #: new anticoagulation of ECMO
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Hemorrhage

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