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

Not Applicable

Active, not recruiting

• Conditions: Thrombosis; Hemorrhage; Extracorporeal Membrane Oxygenation Complication; Heparin Overdose
• Interventions: Diagnostic Test: Thepeautic-heparin therapy; Diagnostic Test: D-dimer-guided adjustment stratege

• Registration Number: NCT03261284
• Lead Sponsor: Wuhan Asia Heart Hospital

Brief Summary

This was a prospective, cohort study.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-24
• Study Start: 2019-03-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-18
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Control group	Thepeautic-heparin therapy	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.
DIAMOND group	D-dimer-guided adjustment stratege	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).

Primary Outcome Measures

Name	Time	Method
Thrombotic events	24 months	Stroke, DVT, PE, Peripheral arterial embolism, ACS etc.
hemorrhagic events	24 months	cerebral hemorrhage,Gastrointestinal bleeding etc.

Secondary Outcome Measures

Name	Time	Method
all-cause deaths	24 months	all-cause deaths

Trial Locations

Locations (1)

Zhang litao; 🇨🇳 Wuhan, Hubei, China