When Heparin Stopped for Anticoagulation During ECMO Decannulation

Extracorporeal Membrane Oxygenation Clinical Trial

Official title:

A Randomized Controlled Pilot Trial of When Heparin Stopped for Anticoagulation During Extracorporeal Membrane Oxygenation Decannulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05239637
• Other study ID #: LHGJ20210421
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: October 2023

Study information

• Verified date: February 2022
• Source: Second Affiliated Hospital of Zhengzhou University
• Contact: Li yahui, Master
• Phone: +8618530060930
• Email: zdyxyliyahui[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation

Intervention

Other:
• Heparin stopped before ECMO decannulation
Heparin has been stopped for 1 hour before ECMO decannulation;The cannulas can be removed immediately with clots larger than 5 mm or enlarging clots in the circuit.
• Heparin reduced after ECMO decannulation
Heparin gradually reduced within 24 hours after ECMO decannulation, If excess bleeding occured,decrease the heparin infusion rapidly or turn the heparin off immediately. Protamine can be given to reversing heparin if necessary.

Locations

Country	Name	City	State
China	General ICU of the second affiliated hospital of zhengzhou university	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

References & Publications (1)

Tonna JE, Abrams D, Brodie D, Greenwood JC, Rubio Mateo-Sidron JA, Usman A, Fan E. Management of Adult Patients Supported with Venovenous Extracorporeal Membrane Oxygenation (VV ECMO): Guideline from the Extracorporeal Life Support Organization (ELSO). ASAIO J. 2021 Jun 1;67(6):601-610. doi: 10.1097/MAT.0000000000001432. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of bleeding and clotting complications		72 hours after decannulation
Secondary	ICU mortality		1 day after ICU discharge
Secondary	28-days mortality		28 days after decannulation
Secondary	Prothrombin time	Measured at the laboratory	1 day and 3 days after decannulation
Secondary	Activated partial thromboplastin time	Measured at the laboratory	1 day and 3 days after decannulation
Secondary	International normalised ratio	Measured at the laboratory	1 day and 3 days after decannulation
Secondary	Fibrinogen	Measured at the laboratory	1 day and 3 days after decannulation
Secondary	D-dimer	Measured at the laboratory	1 day and 3 days after decannulation
Secondary	R time	Time to initial fibrin formation in minutes	1 day and 3 days after decannulation
Secondary	K time	Minutes to 20 mm clot strength	1 day and 3 days after decannulation
Secondary	a angle	Rate of clot strengthening	1 day and 3 days after decannulation
Secondary	Maximum amplitude(MA)	MA represents the ultimate strength of the fibrin clot in mm	1 day and 3 days after decannulation
Secondary	LY30	Degree of clot lysis at 30 minutes	1 day and 3 days after decannulation
Secondary	Volume of packed red cells transfusion		3 days after decannulation

External Links

•   The chinese thoracis society recommended that heparin should not be discontinued immediately before ECMO decannulation