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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06094387

Acronym

THROM-CRIT

Enrollment

Registered

2023-10-23

Start date

2024-04-06

Completion date

2025-04-01

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Line Complication, Thrombosis, Venous

Keywords

Thrombin generation, Central line related thrombosis

Brief summary

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

Interventions

DIAGNOSTIC_TESTThrombin generation assay

Thrombin generation parameters in patients receiving central catheter insertion

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026