New Anticoagulation Strategies of VV-ECMO

NCT03497338 | Withdrawn

• 1 other identifier: new anticoagulation of ECMO
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

the patients received ECMO support

You may qualify if:

• age more than 18 years old, VV-ECMO is estimated more than 3 days

You may not qualify if:

• hemorrhage before VV-ECMO established, VV-ECMO more than 48 hours before admitted, VV-ECMO is estimated less than 3 days

Sponsors & Collaborators

• Xiao Tang: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100020, China

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 13, 2018
• Study Start: April 1, 2018
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

CN (1)