Extracorporeal Membrane Oxygenation ComplicationDIAMONDNCT03261284
D-dimer to Improve Anticoagulation Outcome During ECMO loNg-term supporteD
A study testing D-dimer-guided adjustment stratege and Thepeautic-heparin therapy in people with Extracorporeal Membrane Oxygenation Complication and Thrombosis, run by Wuhan Asia Heart Hospital at 1 site in China.
Trial summary
This was a prospective, cohort study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication, Thrombosis, Hemorrhage
- What is being tested?
- D-dimer-guided adjustment stratege and Thepeautic-heparin therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients
- Receiving ECMO surpport for any reason
Who cannot join
- The duration of ECMO surpport was less than 24 hours .
- Those who had difficulty in compliance or were unavailable for follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: D-dimer to Improve Anticoagulation Management in Adult Patients Supported With Extracorporeal Membrane Oxygenation: a Prospective Cohort Study
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.
- Conditions
- Extracorporeal Membrane Oxygenation Complication, Thrombosis, Hemorrhage, Heparin Overdose
- Being tested
- D-dimer-guided adjustment stratege, Thepeautic-heparin therapy
- Keywords
- D-dimer, Extracorporeal Membrane Oxygenation, heparin, anticoagulant
- Medical subject headings
- Thrombosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-dimer-guided adjustment strategeDiagnostic test
Also called Heparin
D-dimer-guided adjustment stratege
Thepeautic-heparin therapyDiagnostic test
0.3-0.7U/ml of anti-Xa activity or APTT 1.5-2.5 times of control
| Study group | Role | What they receive |
|---|---|---|
| DIAMOND group | Experimental | 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). Receives: Diagnostic Test: D-dimer-guided adjustment stratege |
| Control group | Active comparator | 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. Receives: Diagnostic Test: Thepeautic-heparin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombotic events
Stroke, DVT, PE, Peripheral arterial embolism, ACS etc.
Measured: 24 months
hemorrhagic events
cerebral hemorrhage,Gastrointestinal bleeding etc.
Measured: 24 months
Secondary outcomes (1)
all-cause deaths
all-cause deaths
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start1 Mar 2019
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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).
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Asia Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Litao Zhang, Wuhan Asia Heart Hospital
- Investigators
- Zhenlu ZHANG, MD,PhD, Study director, Wuhan Asia Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261284
- Sponsor's protocol ID
- 2017-P-032
- Acronym
- DIAMOND
- Status last verified
- Apr 2023
- First submitted
- 22 Aug 2017
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-dimer to Improve Anticoagulation Management in Adult Patients Supported With Extracorporeal Membrane Oxygenation: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03261284
- Acronym / sponsor ID
- DIAMOND / 2017-P-032
- Conditions
- Extracorporeal Membrane Oxygenation Complication, Thrombosis, Hemorrhage, Heparin Overdose
- Keywords
- D-dimer, Extracorporeal Membrane Oxygenation, heparin, anticoagulant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wuhan Asia Heart HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| DIAMOND group | Experimental | Diagnostic Test: D-dimer-guided adjustment strategeD-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). |
| Control group | Active comparator | Diagnostic Test: Thepeautic-heparin therapyHeparin 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult Patients
- Receiving ECMO surpport for any reason
Key exclusion criteria (2 listed)
- The duration of ECMO surpport was less than 24 hours .
- Those who had difficulty in compliance or were unavailable for follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-dimer-guided adjustment strategeAlso: HeparinD-dimer-guided adjustment stratege | Diagnostic test | DIAMOND group |
| Thepeautic-heparin therapy0.3-0.7U/ml of anti-Xa activity or APTT 1.5-2.5 times of control | Diagnostic test | Control group |
Primary outcome
Thrombotic events
Time frame: 24 months
Stroke, DVT, PE, Peripheral arterial embolism, ACS etc.
hemorrhagic events
Time frame: 24 months
cerebral hemorrhage,Gastrointestinal bleeding etc.
1 secondary outcome
all-cause deaths
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenlu ZHANG, MD,PhD study director
Wuhan Asia Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-dimer-guided adjustment stratege and Thepeautic-heparin therapy in people with Extracorporeal Membrane Oxygenation Complication and Thrombosis, run by Wuhan Asia Heart Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombotic events (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.