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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03261284

Acronym

DIAMOND

Enrollment

300

Registered

2017-08-24

Start date

2019-03-01

Completion date

2023-12-30

Last updated

2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extracorporeal Membrane Oxygenation Complication, Hemorrhage, Heparin Overdose, Thrombosis

Keywords

D-dimer, Extracorporeal Membrane Oxygenation, heparin, anticoagulant

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.

Interventions

DIAGNOSTIC_TESTD-dimer-guided adjustment stratege

D-dimer-guided adjustment stratege

DIAGNOSTIC_TESTThepeautic-heparin therapy

0.3-0.7U/ml of anti-Xa activity or APTT 1.5-2.5 times of control

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention 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).

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
all-cause deaths	24 months	all-cause deaths

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026