NCT06094387TerminatedNot Applicable
The Use of Thrombin Generation Assay in Detection of Central Line Related Thrombosis (CRT) in Critically Ill Patients
Queen Mary Hospital, Hong Kong2 sites in 1 country2 target enrollmentStarted: April 6, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- Difference in peak thrombin generation (nM) between patients with and without central line related thrombosis
Study Overview
Brief Summary
To study thrombin generation parameters in critically ill patients with and without central line related thrombosis (CRT).
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Wincy Wing-Sze Ng
Associate Consultant, Adult Intensive Care Unit
Queen Mary Hospital, Hong Kong
Study Sites (2)
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