New Anticoagulation Strategies of VV-ECMO

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hemorrhage

• Study Type: Observational

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Department of respiratory and critical care medicine,Beijing Chao-yang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

the patients received ECMO support

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Xiao Tang

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: new anticoagulation of ECMO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No