Catheter ThrombosisCRT-PERSISTNCT07473284
Incidence and Characteristic of CRT Persistent After Catheter Extraction in ICU Patients
An observational study of Catheter Thrombosis and Post Thrombotic Syndrome, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Thrombosis, Post Thrombotic Syndrome, Pulmonary Embolism (Diagnosis)
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- age over 18 years
- ICU hospitalization
- signed informed consent
- an indwelling central venous catheter planned for extraction
Who cannot join
- age under 18 years
- local pathology precluding ultrasound examination
- disagreement with participation in the study
About this study
Official title: Incidence and Characteristics of Venous Catheter-related Thrombosis Persisting After Catheter Removal in Intensive Care Unit Patients.
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:
- What is the incidence of CRT that persists after catheter extraction in patients hospitalized in the intensive care unit?
- What are the risk factors for this phenomenon?
- What is the fate of such a thrombus, including recanalization or the development of complications such as pulmonary embolism or post-thrombotic syndrome?
Read the detailed description
Thrombosis associated with an indwelling central venous catheter (CRT) is a significant phenomenon associated with intensive care. Its incidence can reach up to 41% in intensive care units despite adequate thromboprophylaxis. It manifests itself as the formation of a fibrin coating, thrombotic occlusion of the catheter, mural thrombosis, or complete venous thrombosis. CRT is a frequent reason for catheter removal. However, in these situations, it is not possible to reliably predict the fate of the thrombosis - whether embolization of the thrombus occurs, its removal together with the extracted catheter, or its persistence in the venous bed. Based on our previous clinical observations and studies, it can be stated that in some patients the thrombus is fixed not only to the catheter itself, but also to the venous wall at the site of catheter insertion. After its extraction, the thrombus may persist in the lumen of the vein at the site of the original puncture. The issue of CRT is almost unexplored in the field of intensive care. There are no reliable data on the true incidence of CRT (which is probably underestimated), nor are there standardized recommendations on how to deal with proven thrombosis, what risks it poses to the patient, and whether it is appropriate to perform targeted CRT screening. It is particularly important to identify how often CRT persists after catheter removal, as these patients may be candidates for anticoagulant treatment. Although this fact can significantly influence the therapy strategy both during the ICU stay and after discharge from intensive care, it is a phenomenon that has not been described in detail in the literature. Therefore, we decided to conduct a prospective observational study in which we want to address this specific problem.
Main objectives of the study:
- To determine the incidence of venous thrombosis associated with an indwelling central venous catheter that persists in the vein after catheter removal.
- To describe the detailed characteristics of this phenomenon in terms of risk factors for thrombosis depending on the type of catheter, insertion site, duration of insertion, and other demographic and clinical parameters. 3. To describe the course of subsequent recanalization of the thrombus and the occurrence of potential complications of thrombosis.
- Being tested
- No Interventions
- Keywords
- CRT, Persistent thrombosis, Thrombotic complication
- Medical subject headings
- Postthrombotic Syndrome, Pulmonary Embolism, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
This is an observational study - no interventions will be performed on patients.
| Study group | Role | What they receive |
|---|---|---|
| Observation Cohort | All patient who met inclusion criteria will be enrolled into this observation cohort Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of catheter related thrombosis persisting in vein after catheter removal.
Measured: 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
Especially risk factors for thrombosis depending on the type of catheter, insertion site, duration of insertion, and other demographic and clinical parameters.
Measured: From date of randomization until last patient is enrolled, up to 30.9.2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473284
- Sponsor's protocol ID
- CRT-PERSIST
- Acronym
- CRT-PERSIST
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Characteristics of Venous Catheter-related Thrombosis Persisting After Catheter Removal in Intensive Care Unit Patients.
- ClinicalTrials.gov ID
- NCT07473284
- Acronym / sponsor ID
- CRT-PERSIST / CRT-PERSIST
- Keywords
- CRT, Persistent thrombosis, Thrombotic complication
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.University, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the incidence of CRT that persists after catheter extraction in patients hospitalized in the intensive care unit?
- What are the risk factors for this phenomenon?
- What is the fate of such a thrombus, including recanalization or the development of complications such as pulmonary embolism or post-thrombotic syndrome?
Detailed description
Thrombosis associated with an indwelling central venous catheter (CRT) is a significant phenomenon associated with intensive care. Its incidence can reach up to 41% in intensive care units despite adequate thromboprophylaxis. It manifests itself as the formation of a fibrin coating, thrombotic occlusion of the catheter, mural thrombosis, or complete venous thrombosis. CRT is a frequent reason for catheter removal. However, in these situations, it is not possible to reliably predict the fate of the thrombosis - whether embolization of the thrombus occurs, its removal together with the extracted catheter, or its persistence in the venous bed. Based on our previous clinical observations and studies, it can be stated that in some patients the thrombus is fixed not only to the catheter itself, but also to the venous wall at the site of catheter insertion. After its extraction, the thrombus may persist in the lumen of the vein at the site of the original puncture. The issue of CRT is almost unexplored in the field of intensive care. There are no reliable data on the true incidence of CRT (which is probably underestimated), nor are there standardized recommendations on how to deal with proven thrombosis, what risks it poses to the patient, and whether it is appropriate to perform targeted CRT screening. It is particularly important to identify how often CRT persists after catheter removal, as these patients may be candidates for anticoagulant treatment. Although this fact can significantly influence the therapy strategy both during the ICU stay and after discharge from intensive care, it is a phenomenon that has not been described in detail in the literature. Therefore, we decided to conduct a prospective observational study in which we want to address this specific problem.
Main objectives of the study:
- To determine the incidence of venous thrombosis associated with an indwelling central venous catheter that persists in the vein after catheter removal.
- To describe the detailed characteristics of this phenomenon in terms of risk factors for thrombosis depending on the type of catheter, insertion site, duration of insertion, and other demographic and clinical parameters. 3. To describe the course of subsequent recanalization of the thrombus and the occurrence of potential complications of thrombosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation Cohort | – | Other: No InterventionsAll patient who met inclusion criteria will be enrolled into this observation cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- age over 18 years
- ICU hospitalization
- signed informed consent
- an indwelling central venous catheter planned for extraction
Key exclusion criteria (3 listed)
- age under 18 years
- local pathology precluding ultrasound examination
- disagreement with participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionsThis is an observational study - no interventions will be performed on patients. | Other | Observation Cohort |
Primary outcome
Incidence of catheter related thrombosis persisting in vein after catheter removal.
Time frame: Primary outcome will be known after From date of randomization until last patient is enrolled, up to 30.9.2028
1 secondary outcome
Description of detailed characteristics associated with persisting CRT after extraction
Time frame: From date of randomization until last patient is enrolled, up to 30.9.2028
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter Thrombosis and Post Thrombotic Syndrome, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of catheter related thrombosis persisting in vein after catheter removal. (time frame: Primary outcome will be known after From date of randomization until last patient is enrolled, up to 30.9.2028). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.