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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06094387
Other study ID # 20230905-017-000
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 6, 2024
Est. completion date April 1, 2025

Study information

Verified date April 2024
Source Queen Mary Hospital, Hong Kong
Contact Wincy Ng, MRCP
Phone 22553111
Email wincyngwingsze@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To study thrombin generation parameters in critically ill patients with and without central line related thrombosis (CRT).


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date April 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Intervention

Diagnostic Test:
Thrombin generation assay
Thrombin generation parameters in patients receiving central catheter insertion

Locations

Country Name City State
Hong Kong Queen Mary Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 From the time of CVC insertion to the time of CVC removal
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