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This was a prospective, cohort study.
Adult Patients receiving ECMO surpport in Wuhan Asia Heart Hospital were enrolled by cohort. Unfractionated heparin was used for Anticoagulation therapy, APTT or Anti-Xa activity is monitored for dose adjustment. Meanwhile, D-dimer is mornitored. If D-dimer levels continue to rise (>1.5 times previous result ), increase the dose of heparin to reach the upper limit of the treatment target; If the D-dimer levels is stable (<1.5 times previous result ) or is decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or decreased (active bleeding). All patients were followed up The occurrence of endpoints during in-hospital and 30 days after discharge, including bleeding events, thrombotic events and all-cause deaths were recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DIAMOND group | Experimental | D-dimer and anti-Xa are mornitored. If D-dimer levels continue to rise (>1.5 times previous result ), increase the dose of heparin to reach the upper limit of the treatment target; If the D-dimer levels is stable (<1.5 times previous result ) or is decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or decreased (active bleeding). |
|
| Control group | Active Comparator | Heparin dose adjusted according to anti-Xa activity or activated partial thromboplastin time (aPTT). The target range is aPTT 1.5 to 2.5 times the upper limit of normal or therapeutic anti-Xa levels (0.3 U/ml to 0.7 U/ml) for unfractionated heparin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-dimer-guided adjustment stratege | Diagnostic Test | D-dimer-guided adjustment stratege |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thrombotic events | Stroke, DVT, PE, Peripheral arterial embolism, ACS etc. | 24 months |
| hemorrhagic events | cerebral hemorrhage,Gastrointestinal bleeding etc. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| all-cause deaths | all-cause deaths | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhenlu ZHANG, MD,PhD | Wuhan Asia Heart Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhang litao | Wuhan | Hubei | 430022 | China |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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D-dimer is mornitored. If D-dimer levels continue to rise (>1.5 times previous result ), increase the dose of heparin to reach the upper limit of the treatment target; If the D-dimer levels is stable (<1.5 times previous result ) or is decreasing, the anticoagulation dose is maintained at current level (no active bleeding) or decreased (active bleeding).
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| Thepeautic-heparin therapy | Diagnostic Test | 0.3-0.7U/ml of anti-Xa activity or APTT 1.5-2.5 times of control |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |