The Use of Thrombin Generation Assay in Detection of Central Line Related Thrombosis (CRT) in Critically Ill Patients

Thrombosis, Venous Clinical Trial

— THROM-CRIT  

Official title:

The Use of Thrombin Generation Assay in Detection of Central Line Related Thrombosis (CRT) in Critically Ill Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094387
• Other study ID #: 20230905-017-000
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Central Line Complication
• Thrombosis
• Thrombosis, Venous
• Venous Thrombosis

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