D-dimer to Improve Anticoagulation Outcome During ECMO loNg-term supporteD

Study Overview
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Brief Summary
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This was a prospective, cohort study.

Detailed Description
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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.

Official Title
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D-dimer to Improve Anticoagulation Management in Adult Patients Supported With Extracorporeal Membrane Oxygenation: a Prospective Cohort Study

Conditions
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Extracorporeal Membrane Oxygenation Complication, Thrombosis, Hemorrhage, Heparin Overdose

Intervention / Treatment
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* Diagnostic Test: D-dimer-guided adjustment stratege
* Diagnostic Test: Thepeautic-heparin therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Patients Receiving ECMO surpport for any reason Exclusion Criteria: The duration of ECMO surpport was less than 24 hours . Those who had difficulty in compliance or were unavailable for follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DIAMOND group<br>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). | Diagnostic Test: D-dimer-guided adjustment stratege<br>* D-dimer-guided adjustment stratege<br>* Other names: Heparin;|
| Active Comparator: Control group<br>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. | Diagnostic Test: Thepeautic-heparin therapy<br>* 0.3-0.7U/ml of anti-Xa activity or APTT 1.5-2.5 times of control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause deaths | all-cause deaths | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heparin, anticoagulant, Extracorporeal Membrane Oxygenation, D-dimer