Central Line ComplicationTHROM-CRITNCT06094387
The Use of Thrombin Generation Assay in Detection of Central Line Related Thrombosis (CRT) in Critically Ill Patients
An observational study of Central Line Complication and Thrombosis, Venous, run by Queen Mary Hospital, Hong Kong at 1 site in Hong Kong.
Trial summary
To study thrombin generation parameters in critically ill patients with and without central line related thrombosis (CRT). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Central Line Complication, Thrombosis, Venous
- What is being tested?
- Thrombin generation assay
- How many people
- 2 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 Apr 2024to 1 Apr 2025
- How long will I take part?
- 6 Months
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring central catheter insertion in the ICU
Who may be able to join
- Age ≧ 18; AND
- Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital in Hong Kong; AND
- Clinically indicated for central catheter insertion, which includes central venous catheters and dialysis catheters; AND
- Expected to have the central catheter in place for at least 5 days in their ICU stay.
Who cannot join
- Patients known to have active venous thromboembolism including deep venous thrombosis or pulmonary embolism;
- Patients known to have hypercoagulable states, e.g., hereditary thrombophilia, antiphospholipid syndrome; OR
- Patients with active solid organ or hematological malignancies; OR
- Patients already receiving therapeutic anticoagulation prior to study recruitment; OR
- Patients with thrombosis detected in the insertion site before central catheter insertion; OR
- Patients with a central venous catheter already in place prior to ICU admission; OR
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- Patients admitted to the ICU for post-operative care; OR
- Patients admitted to the ICU for trauma care; OR
- Patients requiring extra-corporeal life support (ECLS); OR
- Patients with poor window or inaccessible for ultrasonographic examination; OR
- Pregnancy/post-partum within 6 weeks
Trial locations and contacts
1 site in 1 country.
About this study
To study thrombin generation parameters in critically ill patients with and without central line related thrombosis (CRT).
- Conditions
- Central Line Complication, Thrombosis, Venous
- Being tested
- Thrombin generation assay
- Keywords
- Thrombin generation, Central line related thrombosis
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombin generation assayDiagnostic test
Thrombin generation parameters in patients receiving central catheter insertion
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in peak thrombin generation (nM) between patients with and without central line related thrombosis
The primary outcome measure is the difference in peak thrombin generation (nM) between patients with and without central line related thrombosis
Measured: From the time of CVC insertion to the time of CVC removal
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 start6 Apr 2024
- Primary completion1 Dec 2024
- Study completion1 Apr 2025
Why it stopped: Administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Line 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
- Target duration
- 6 Months
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
- NCT06094387
- Sponsor's protocol ID
- 20230905-017-000
- Acronym
- THROM-CRIT
- Status last verified
- Sep 2026
- First submitted
- 13 Oct 2023
- Last updated
- 4 Sep 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Thrombin Generation Assay in Detection of Central Line Related Thrombosis (CRT) in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06094387
- Acronym / sponsor ID
- THROM-CRIT / 20230905-017-000
- Conditions
- Central Line Complication, Thrombosis, Venous
- Keywords
- Thrombin generation, Central line related thrombosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Administrative reasons
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Queen Mary Hospital, Hong KongUniversity, hospital or other
- Study start
- 6 Apr 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Apr 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 thrombin generation parameters in critically ill patients with and without central line related thrombosis (CRT).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring central catheter insertion in the ICU
Key inclusion criteria (4 listed)
- Age ≧ 18; AND
- Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital in Hong Kong; AND
- Clinically indicated for central catheter insertion, which includes central venous catheters and dialysis catheters; AND
- Expected to have the central catheter in place for at least 5 days in their ICU stay.
Key exclusion criteria (11 listed)
- Patients known to have active venous thromboembolism including deep venous thrombosis or pulmonary embolism;
- Patients known to have hypercoagulable states, e.g., hereditary thrombophilia, antiphospholipid syndrome; OR
- Patients with active solid organ or hematological malignancies; OR
- Patients already receiving therapeutic anticoagulation prior to study recruitment; OR
- Patients with thrombosis detected in the insertion site before central catheter insertion; OR
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 |
|---|---|---|
| Thrombin generation assayThrombin generation parameters in patients receiving central catheter insertion | Diagnostic test | – |
Primary outcome
Difference in peak thrombin generation (nM) between patients with and without central line related thrombosis
Time frame: From the time of CVC insertion to the time of CVC removal
The primary outcome measure is the difference in peak thrombin generation (nM) between patients with and without central line related thrombosis
Results and safety
The study was stopped early (reason given: Administrative reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 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 Central Line Complication and Thrombosis, Venous, 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 4 Sep 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 was stopped early (reason given: Administrative reasons). 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?
Difference in peak thrombin generation (nM) between patients with and without central line related thrombosis (time frame: From the time of CVC insertion to the time of CVC removal). 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 4 Sep 2026.