Extracorporeal Membrane Oxygenation
Conditions
Keywords
Extracorporeal Membrane Oxygenation, Heparin, Anticoagulants, Decannulation, Randomized Controlled
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).
Interventions
OTHERHeparin 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.
OTHERHeparin 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.
Sponsors
Second Affiliated Hospital of Zhengzhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of bleeding and clotting complications | 72 hours after decannulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-days mortality | 28 days after decannulation | — |
| Prothrombin time | 1 day and 3 days after decannulation | Measured at the laboratory |
| Activated partial thromboplastin time | 1 day and 3 days after decannulation | Measured at the laboratory |
| International normalised ratio | 1 day and 3 days after decannulation | Measured at the laboratory |
| Fibrinogen | 1 day and 3 days after decannulation | Measured at the laboratory |
| D-dimer | 1 day and 3 days after decannulation | Measured at the laboratory |
| ICU mortality | 1 day after ICU discharge | — |
| 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 |
| Volume of packed red cells transfusion | 3 days after decannulation | — |
| R time | 1 day and 3 days after decannulation | Time to initial fibrin formation in minutes |
Countries
China
Contacts
Primary ContactLi yahui, Master
Backup ContactLu yanqiu, Doctor
Outcome results
None listed