Extracorporeal Circulation; ComplicationsDIC-ECMONCT06095518
DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study
An observational study of Extracorporeal Circulation; Complications and Extracorporeal Membrane Oxygenation Complication, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.
Trial summary
To study the correlation between novel DIC markers and thrombin generation parameters with thrombotic and hemorrhagic complications of patients on ECMO support. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Extracorporeal Circulation; Complications, Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- DIC markers and Thrombin Generation Parameters
- How many people
- 49 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 May 2023to 31 Dec 2025
- Phase
- Observational
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients requiring ECMO support
Who may be able to join
- Age ≧ 18; AND
- Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital or Tuen Mun Hospital in Hong Kong; AND
- Require either veno-arterial (VA) or veno-venous (VV) extracorporeal membrane oxygenation (ECMO) support.
Who cannot join
- Patients who are on central VA-ECMO support; OR
- Patients with missing clinical data; OR
- Patients with pre-existing thromboembolism requiring long term anticoagulation prior to ECMO cannulation; OR
- Post-operative admissions
Trial locations and contacts
1 site in 1 country.
About this study
To study the correlation between novel DIC markers and thrombin generation parameters with thrombotic and hemorrhagic complications of patients on ECMO support.
- Conditions
- Extracorporeal Circulation; Complications, Extracorporeal Membrane Oxygenation Complication
- Being tested
- DIC markers and Thrombin Generation Parameters
- Keywords
- ECMO, Thrombosis, Haemorrhage
- Medical subject headings
- Thrombosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIC markers and Thrombin Generation ParametersDiagnostic test
Observation of DIC markers and thrombin generation parameters in patients with and without thrombotic and hemorrhagic complications
| Study group | Role | What they receive |
|---|---|---|
| Adult Intensive Care Unit, Queen Mary Hospital | Not described Receives: Diagnostic Test: DIC markers and Thrombin Generation Parameters | |
| Department of Intensive Care Unit, Tuen Mun Hospital | Not described Receives: Diagnostic Test: DIC markers and Thrombin Generation Parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of thrombotic and hemorrhagic events
Thrombotic events include circuit-related thrombosis (e.g. oxygenator failure requiring circuit change) OR Non-circuit-related thrombosis (e.g. new pulmonary embolism or deep vein thrombosis while on ECMO.
Hemorrhagic events include bleeding at critical sites or requiring interventions.
Measured: From the start of ECMO support to the end of ECMO support (which can be variable, typically around 5 days to 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start30 May 2023
- Primary completion7 Apr 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Circulation; ComplicationsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wincy Wing-Sze Ng, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095518
- Sponsor's protocol ID
- UW 23-259
- Acronym
- DIC-ECMO
- Status last verified
- Jul 2026
- First submitted
- 13 Oct 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study
- ClinicalTrials.gov ID
- NCT06095518
- Acronym / sponsor ID
- DIC-ECMO / UW 23-259
- Conditions
- Extracorporeal Circulation; Complications, Extracorporeal Membrane Oxygenation Complication
- Keywords
- ECMO, Thrombosis, Haemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Queen Mary Hospital, Hong KongUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 23 Oct 2023 (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.
To study the correlation between novel DIC markers and thrombin generation parameters with thrombotic and hemorrhagic complications of patients on ECMO support.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult Intensive Care Unit, Queen Mary Hospital | – | Diagnostic Test: DIC markers and Thrombin Generation Parameters |
| Department of Intensive Care Unit, Tuen Mun Hospital | – | Diagnostic Test: DIC markers and Thrombin Generation Parameters |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients requiring ECMO support
Key inclusion criteria (3 listed)
- Age ≧ 18; AND
- Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital or Tuen Mun Hospital in Hong Kong; AND
- Require either veno-arterial (VA) or veno-venous (VV) extracorporeal membrane oxygenation (ECMO) support.
Key exclusion criteria (4 listed)
- Patients who are on central VA-ECMO support; OR
- Patients with missing clinical data; OR
- Patients with pre-existing thromboembolism requiring long term anticoagulation prior to ECMO cannulation; OR
- Post-operative admissions
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 |
|---|---|---|
| DIC markers and Thrombin Generation ParametersObservation of DIC markers and thrombin generation parameters in patients with and without thrombotic and hemorrhagic complications | Diagnostic test | Adult Intensive Care Unit, Queen Mary Hospital, Department of Intensive Care Unit, Tuen Mun Hospital |
Primary outcome
Composite of thrombotic and hemorrhagic events
Time frame: From the start of ECMO support to the end of ECMO support (which can be variable, typically around 5 days to 1 week)
Thrombotic events include circuit-related thrombosis (e.g. oxygenator failure requiring circuit change) OR Non-circuit-related thrombosis (e.g. new pulmonary embolism or deep vein thrombosis while on ECMO. Hemorrhagic events include bleeding at critical sites or requiring interventions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Circulation; Complications and Extracorporeal Membrane Oxygenation Complication, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 20 Jul 2026. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite of thrombotic and hemorrhagic events (time frame: From the start of ECMO support to the end of ECMO support (which can be variable, typically around 5 days to 1 week)). 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 20 Jul 2026.