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

Wuhan Asia Heart Hospital

Status: Active, not recruiting

Conditions: Hemorrhage; Extracorporeal Membrane Oxygenation Complication; Thrombosis; Heparin Overdose

Treatments: Diagnostic Test: Thepeautic-heparin therapy; Diagnostic Test: D-dimer-guided adjustment stratege

Study type: Interventional

Funder types: Other

Identifiers

NCT03261284

2017-P-032

Details and patient eligibility

About

This was a prospective, cohort study.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

DIAMOND group

Experimental group

Description:

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).

Treatment:

Diagnostic Test: D-dimer-guided adjustment stratege

Control group

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Thepeautic-heparin therapy