ClinicalTrials.gg
Status unknownNCT03261284DIAMONDUpdated Apr 18, 2023

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

An interventional study of D-dimer-guided adjustment stratege and Thepeautic-heparin therapy in Extracorporeal Membrane Oxygenation Complication, Thrombosis and Hemorrhage, sponsored by Wuhan Asia Heart Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by Wuhan Asia Heart Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This was a prospective, cohort study.

Read the 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.

02

Conditions studied

  • Extracorporeal Membrane Oxygenation Complication
  • Thrombosis
  • Hemorrhage
  • Heparin Overdose

Keywords

  • D-dimer
  • Extracorporeal Membrane Oxygenation
  • heparin
  • anticoagulant
03

In context

Thrombosis

955 studies on the registry are indexed under Thrombosis; 171 are open to participants now.

This study's planned enrollment of 300 is above the median of 83 across 530 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Wuhan Asia Heart Hospital is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult Patients
  • Receiving ECMO surpport for any reason

Exclusion criteria

Exclusion Criteria:

  • The duration of ECMO surpport was less than 24 hours .
  • Those who had difficulty in compliance or were unavailable for follow-up.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    DIAMOND group

    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

  • Active comparator
    Control group

    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

Interventions

  • Diagnostic testD-dimer-guided adjustment stratege

    D-dimer-guided adjustment stratege

    Also known as: Heparin

  • Diagnostic testThepeautic-heparin therapy

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

06

What researchers measure

Primary outcomes

  1. Thrombotic events

    Stroke, DVT, PE, Peripheral arterial embolism, ACS etc.

    Time frame: 24 months

  2. hemorrhagic events

    cerebral hemorrhage,Gastrointestinal bleeding etc.

    Time frame: 24 months

Secondary outcomes

  1. all-cause deaths

    all-cause deaths

    Time frame: 24 months

07

Study locations

1 site
  • Zhang litao
    Wuhan, Hubei 430022, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2019 (actual). Primary completion is estimated for Dec 2023, 57 months after the start.

Of 108 non-industry interventional studies with no phase under Thrombosis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's planned 57 months is above that.

Counting every sponsor, half of 115 studies reached it within 24 months; a quarter within 9 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2017
First posted
Aug 24, 2017
StartActual
Mar 1, 2019
Primary completionEst.
Dec 1, 2023
CompletionEst.
Dec 30, 2023
Last update
Apr 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03261284
Lead sponsor
Wuhan Asia Heart Hospital
Responsible party
Litao Zhang (Director of Thrombosis centre, Wuhan Asia Heart Hospital) — Principal investigator
First posted
Aug 24, 2017
Start date
Mar 1, 2019
Primary completion
Dec 1, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Apr 18, 2023

Study contacts

Zhenlu ZHANG, MD,PhD
study director · Wuhan Asia Heart Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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