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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
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 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.
General ICU of the second affiliated hospital of zhengzhou university
Zhengzhou, Henan, China
RECRUITINGIncidence of bleeding and clotting complications
Time frame: 72 hours after decannulation
ICU mortality
Time frame: 1 day after ICU discharge
28-days mortality
Time frame: 28 days after decannulation
Prothrombin time
Measured at the laboratory
Time frame: 1 day and 3 days after decannulation
Activated partial thromboplastin time
Measured at the laboratory
Time frame: 1 day and 3 days after decannulation
International normalised ratio
Measured at the laboratory
Time frame: 1 day and 3 days after decannulation
Fibrinogen
Measured at the laboratory
Time frame: 1 day and 3 days after decannulation
D-dimer
Measured at the laboratory
Time frame: 1 day and 3 days after decannulation
R time
Time to initial fibrin formation in minutes
Time frame: 1 day and 3 days after decannulation
K time
Minutes to 20 mm clot strength
Time frame: 1 day and 3 days after decannulation
α angle
Rate of clot strengthening
Time frame: 1 day and 3 days after decannulation
Maximum amplitude(MA)
MA represents the ultimate strength of the fibrin clot in mm
Time frame: 1 day and 3 days after decannulation
LY30
Degree of clot lysis at 30 minutes
Time frame: 1 day and 3 days after decannulation
Volume of packed red cells transfusion
Time frame: 3 days after decannulation
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