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

Recruiting

• Conditions: Central Line Complication; Thrombosis, Venous

• Registration Number: NCT06094387
• Lead Sponsor: Queen Mary Hospital, Hong Kong

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-23
• Status Verified: 2024-04
• Study Start: 2024-04-06
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2024-12-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	The primary outcome measure is the difference in peak thrombin generation (nM) between patients with and without central line related thrombosis

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong