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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previous | Experimental | Heparin stopped before ECMO decannulation |
|
| Afterwards | Experimental | Heparin reduced after ECMO decannulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of bleeding and clotting complications | 72 hours after decannulation |
| Measure | Description | Time Frame |
|---|---|---|
| ICU mortality | 1 day after ICU discharge | |
| 28-days mortality | 28 days after decannulation | |
| Prothrombin time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li yahui, Master | Contact | +8618530060930 | zdyxyliyahui@163.com | |
| Lu yanqiu, Doctor | Contact | +8613598862310 | luyanqiu815@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Li yahui, Master | Second Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General ICU of the second affiliated hospital of zhengzhou university | Recruiting | Zhengzhou | Henan | 450000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33965970 | Background | 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. |
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| 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. |
|
Measured at the laboratory |
| 1 day and 3 days after decannulation |
| Activated partial thromboplastin time | Measured at the laboratory | 1 day and 3 days after decannulation |
| International normalised ratio | Measured at the laboratory | 1 day and 3 days after decannulation |
| Fibrinogen | Measured at the laboratory | 1 day and 3 days after decannulation |
| D-dimer | Measured at the laboratory | 1 day and 3 days after decannulation |
| R time | Time to initial fibrin formation in minutes | 1 day and 3 days after decannulation |
| K time | Minutes to 20 mm clot strength | 1 day and 3 days after decannulation |
| α angle | Rate of clot strengthening | 1 day and 3 days after decannulation |
| Maximum amplitude(MA) | MA represents the ultimate strength of the fibrin clot in mm | 1 day and 3 days after decannulation |
| LY30 | Degree of clot lysis at 30 minutes | 1 day and 3 days after decannulation |
| Volume of packed red cells transfusion | 3 days after decannulation |