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

April 8, 2024 updated by: Wincy Wing-Sze Ng, Queen Mary Hospital, Hong Kong
To study thrombin generation parameters in critically ill patients with and without central line related thrombosis (CRT).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients requiring central catheter insertion in the ICU

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the time of CVC insertion to the time of CVC removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary Hospital, Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230905-017-000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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