When Heparin Stopped for Anticoagulation During ECMO Decannulation

Not Applicable

• Conditions: Extracorporeal Membrane Oxygenation
• Interventions: Other: Heparin reduced after ECMO decannulation; Other: Heparin stopped before ECMO decannulation

• Registration Number: NCT05239637
• Lead Sponsor: Second Affiliated Hospital of Zhengzhou University

Brief Summary

Heparin (regular or unfractionated heparin, not low molecular weight heparin) is given as a bolus (50-100 units per kilogram) at the time of extracorporeal membrane oxygenation(ECMO) cannulation, and by continuous infusion during ECMO. Heparin infusion is regulated to keep the whole blood activated clotting time (ACT) or activated partial thromboplastin time (APTT) at a designated level (usually 1.5 times normal for the ACT or APTT measurement system). An elevated ACT or APTT is associated with high risks of early and late complications,such as bleeding,hematoma,pseudoaneurysm,and arterial-venous fistula. Extracorporeal life support organization(ELSO) make recommendation that the cannulas can be removed ideally after the heparin has been stopped for 30 to 60 minutes.However,the Chinese Thoracis Society recommends that heparin should not be discontinued immediately before ECMO decannulation, but gradually reduced within 24 hours, and then low molecular weight heparin is continued to be given for anticoagulation. Therefore,options of which time heparin stopped remain controversial.The investigators conduct this pilot study to investigate the opportunity of heparin stopped for anticoagulation before ECMO decannulation.

Detailed Description

Forty adult patients with cardiac or respiratory failure supported by ECMO are enrolled in the study. Patients are randomly allocated to be treated with either a) heparin has been stopped for 1 hour before ECMO decannulation(regimen A), b) heparin gradually reduced within 24 hours after ECMO decannulation(regimen B).The investigators hypothesize that patients treated with regimen A as compared with patients treated with regimen B would decrease the incidence of complications during the ECMO decannulation period(from 1 hour before ECMO decannulation to 72 hours post decannulation).

Study Timeline

• Study First Submitted: 2021-12-21
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-13
• Study Start: 2022-02-15
• Study First Posted: 2022-02-15
• Last Update Submitted: 2022-03-11
• Last Update Posted: 2022-03-15
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• ECMO therapy was instituted to support circulatory and/or respiratory failure;
• Heparin continuous infusion for anticoagulation during ECMO;
• Native cardiac and pulmonary function improve,and the trial off is successful.
• Ensure each patient provides signed and dated informed consent.

Exclusion Criteria

• 1.History of thrombotic diseases or coagulation disorder；
• Thrombosis or bleeding events occurred prior to allocation；
• Heparin stopped prior to allocation；
• Other anticoagulants, antiplatelets, hemostatics and other drugs affected coagulation function have been used；
• The trial off has failed;
• Pregnant and lactating patients;
• Patients participated in the other studies;
• Patients couldn't accept comprehensive treatment;
• Patients couldn't acquire informed consent;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Afterwards	Heparin reduced after ECMO decannulation	Heparin reduced after ECMO decannulation
Previous	Heparin stopped before ECMO decannulation	Heparin stopped before ECMO decannulation

Primary Outcome Measures

Name	Time	Method
Incidence of bleeding and clotting complications	72 hours after decannulation

Secondary Outcome Measures

Name	Time	Method
International normalised ratio	1 day and 3 days after decannulation	Measured at the laboratory
28-days mortality	28 days after decannulation
Prothrombin time	1 day and 3 days after decannulation	Measured at the laboratory
Volume of packed red cells transfusion	3 days after decannulation
D-dimer	1 day and 3 days after decannulation	Measured at the laboratory
R time	1 day and 3 days after decannulation	Time to initial fibrin formation in minutes
ICU mortality	1 day after ICU discharge
Activated partial thromboplastin time	1 day and 3 days after decannulation	Measured at the laboratory
Fibrinogen	1 day and 3 days after decannulation	Measured at the laboratory
K time	1 day and 3 days after decannulation	Minutes to 20 mm clot strength
α angle	1 day and 3 days after decannulation	Rate of clot strengthening
Maximum amplitude（MA）	1 day and 3 days after decannulation	MA represents the ultimate strength of the fibrin clot in mm
LY30	1 day and 3 days after decannulation	Degree of clot lysis at 30 minutes

Trial Locations

Locations (1)

General ICU of the second affiliated hospital of zhengzhou university; 🇨🇳 Zhengzhou, Henan, China