When Heparin Stopped for Anticoagulation During ECMO Decannulation

NCT05239637 | Unknown DMC

• 1 other identifier: LHGJ20210421
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Extracorporeal Membrane Oxygenation

Keywords

Extracorporeal Membrane Oxygenation; Heparin; Anticoagulants; Decannulation; Randomized Controlled

Outcome Measures

Primary Outcomes (1)

• Incidence of bleeding and clotting complications

  72 hours after decannulation

Secondary Outcomes (13)

• ICU mortality

  1 day after ICU discharge

• 28-days mortality

  28 days after decannulation

• Prothrombin time

  1 day and 3 days after decannulation

• Activated partial thromboplastin time

  1 day and 3 days after decannulation

• International normalised ratio

  1 day and 3 days after decannulation

Study Arms (2)

Previous

EXPERIMENTAL

Heparin stopped before ECMO decannulation

Other: Heparin stopped before ECMO decannulation

Afterwards

EXPERIMENTAL

Heparin reduced after ECMO decannulation

Other: Heparin reduced after ECMO decannulation

Interventions

Heparin stopped before ECMO decannulation OTHER

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.

Previous

Heparin reduced after ECMO decannulation OTHER

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.

Afterwards

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Second Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

General ICU of the second affiliated hospital of zhengzhou university

Zhengzhou, Henan, 450000, China

RECRUITING

Related 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.

  PMID: 33965970 BACKGROUND

Related Links

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

Study Officials

• Li yahui, Master

  Second Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li yahui, Master

CONTACT

+8618530060930; zdyxyliyahui@163.com

Lu yanqiu, Doctor

CONTACT

+8613598862310; luyanqiu815@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: February 15, 2022
• Study Start: February 15, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: March 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)