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

NCT06094387 | Recruiting

• 1 other identifier: 20230905-017-000
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Central Line Complication; Thrombosis, Venous

Keywords

Thrombin generation; Central line related thrombosis

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Thrombin generation assay DIAGNOSTIC_TEST

Thrombin generation parameters in patients receiving central catheter insertion

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring central catheter insertion in the ICU

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Wincy Ng, MRCP

CONTACT

22553111; wincyngwingsze@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant, Adult Intensive Care Unit

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 23, 2023
• Study Start: April 6, 2024
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

HK (1)