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NCT03261284 Clinical Trial

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

Thrombosis Clinical Trial

— DIAMOND  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03261284
Other study ID # 2017-P-032
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date December 30, 2023

Study information
Verified date April 2023
Source Wuhan Asia Heart Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This was a prospective, cohort study.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date December 30, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• D-dimer-guided adjustment stratege
D-dimer-guided adjustment stratege
• Thepeautic-heparin therapy
0.3-0.7U/ml of anti-Xa activity or APTT 1.5-2.5 times of control

Locations
Country Name City State
China Zhang litao Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Wuhan Asia Heart Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Thrombotic events Stroke, DVT, PE, Peripheral arterial embolism, ACS etc. 24 months
Primary hemorrhagic events cerebral hemorrhage,Gastrointestinal bleeding etc. 24 months
Secondary all-cause deaths all-cause deaths 24 months
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