Incidence and Characteristic of CRT Persistent After Catheter Extraction in ICU Patients

NCT07473284 | Not Yet Recruiting

• 1 other identifier: CRT-PERSIST
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to describe characteristics of catheter related thrombosis (CRT) that persists after catheter extraction in condition of intensive care unit. The main questions it aims to answer are:

1. 1.What is the incidence of CRT that persists after catheter extraction in patients hospitalized in the intensive care unit?
2. 2.What are the risk factors for this phenomenon?
3. 3.What is the fate of such a thrombus, including recanalization or the development of complications such as pulmonary embolism or post-thrombotic syndrome?

Conditions

Catheter Thrombosis; Post Thrombotic Syndrome; Pulmonary Embolism (Diagnosis)

Keywords

CRT; Persistent thrombosis; Thrombotic complication

Outcome Measures

Primary Outcomes (1)

• Incidence of catheter related thrombosis persisting in vein after catheter removal.

  Primary outcome will be known after From date of randomization until last patient is enrolled, up to 30.9.2028

Secondary Outcomes (1)

• Description of detailed characteristics associated with persisting CRT after extraction

  From date of randomization until last patient is enrolled, up to 30.9.2028

Other Outcomes (1)

• Describe the further course of persisting thrombosis

  From date of randomization until last patient is enrolled, up to 30.9.2028

Study Arms (1)

Observation Cohort

All patient who met inclusion criteria will be enrolled into this observation cohort

Other: No Interventions

Interventions

No Interventions OTHER

This is an observational study - no interventions will be performed on patients.

Observation Cohort

Eligibility Criteria

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

Study Population

The clinical study will include all adult patients with an indwelling central venous catheter hospitalized at the Department of Anesthesiology, Perioperative and Intensive Care Medicine of the Masaryk Hospital in Ústí nad Labem, in whom catheter removal is planned regardless of the cause, and who agreed to participate in the clinical study.

You may qualify if:

• age over 18 years
• ICU hospitalization
• signed informed consent
• an indwelling central venous catheter planned for extraction

You may not qualify if:

• age under 18 years
• local pathology precluding ultrasound examination
• disagreement with participation in the study

Sponsors & Collaborators

• Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.: lead

MeSH Terms

Conditions

Postthrombotic Syndrome; Pulmonary Embolism; Disease

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency; Lung Diseases; Respiratory Tract Diseases; Embolism; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available after publishing the study. The data will be available for 10 years.
• Access Criteria: Data will be accessible publicly in university data repository.