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OpenTrials
Terminated

NCT Number: NCT06094387

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

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

Why the study stopped: Administrative reasons
Terminated

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Mary Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thrombin Generation Assay

Diagnostic Test

Thrombin generation parameters in patients receiving central catheter insertion

Primary outcomes

  1. Difference in peak thrombin generation (nM) between patients with and without central line related thrombosis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Queen Mary Hospital, Hong Kong

Other

Registry information

Acronym: THROM-CRIT

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 23, 2023
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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