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

• Sponsor: Queen Mary Hospital, Hong Kong (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06094387
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Anticipated Duration (Months): 16
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Central Line Complication; Thrombosis, Venous	Diagnostic Test: Thrombin generation assay

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 30 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Use of Thrombin Generation Assay in Detection of Central Line Related Thrombosis (CRT) in Critically Ill Patients
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Apr 1, 2025

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Mary Hospital	Hong Kong		Hong Kong

Sponsors and Collaborators

• Queen Mary Hospital, Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wincy Wing-Sze Ng, Associate Consultant, Adult Intensive Care Unit, Queen Mary Hospital, Hong Kong
• ClinicalTrials.gov Identifier: NCT06094387
• Other Study ID Numbers: 20230905-017-000
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 24, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wincy Wing-Sze Ng, Associate Consultant, Adult Intensive Care Unit, Queen Mary Hospital, Hong Kong: Thrombin generation; Central line related thrombosis
• Additional relevant MeSH terms: Thrombosis; Venous Thrombosis; Thrombin

Study Results

No Results Posted as of Oct 24, 2023