Comparison of Vascular Catheter-Related Thrombosis and Risk Factors After Oncologic and Non-Oncologic Major Surgery

December 4, 2025 updated by: Assistant Prof Levent Özdemir, M.D., Mersin University

Comparison of Vascular Catheter-Related Thrombosis and Risk Factors Using Daily Bedside Ultrasonography After Oncologic and Non-Oncologic Major Surgery

The aim of this study was to prospectively evaluate vascular catheter-related thrombosis and risk factors using daily bedside ultrasonography after oncologic and non-oncologic major surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Vascular catheters (VC) are one of the most frequently performed interventional procedures in both critically ill patients in intensive care units and patients scheduled for major surgery. Recognition of VC-related complications has increased in recent years, and among them, VC-related thrombosis (VCRT) is frequently seen. The reported incidence of VCRT is variable, up to an overall rate of 14-40% for symptomatic events, and may result in pulmonary embolism. Ultrasonography is used frequently and effectively to diagnose intravascular thrombosis and occlusion and provide early intervention. It has been observed that the diagnosis of VCRT can usually be made just before VC is removed or when it becomes symptomatic. Because venous thrombosis formation is a result of altered blood flow, vascular endothelial damage, or altered blood structure, VCRT can occur very early because certain risk factors are present at the time of catheterization. The evolution of VCRT may differ from classic deep vein thrombosis (DVT) depending on existing or removed catheter- or patient-related risk factors. Although there are studies in intensive care patients, the clinical significance of VCRT in patients scheduled for major surgery has not yet been clarified. The time from the first day of catheter placement to the onset of VCRT is not clearly known, and the evolution of VCRT size over time before and after VC removal has not been evaluated. For this reason, it was aimed to evaluate VCRT with ultrasound on a daily basis in the period from insertion to removal of the VC and to evaluate it with a prospective study design in order to detect possible risk factors. Adult patients who will undergo major surgery under elective conditions and are planned to have a central venous catheter inserted will be included in the study. Patients who are decided to have VC implanted will be checked for any thrombus in the vascular structure using ultrasound (US) before the procedure is performed. VC size and length, insertion site, and use of ultrasound guidance will be recorded. Ultrasound detection of VCRT is planned to be performed daily before VC insertion and until VC is removed or the patient is discharged from the intensive care unit. If there is no thrombus between the insertion of the VC and the removal of the VC or until the patient is discharged, patients will be considered as having not developed VCRT. When VCRT is detected, the decision to leave or remove the catheter or initiate therapeutic anticoagulation will be made independently by the patient's responsible physician. A linear probe will be used for ultrasound diagnostic imaging of catheter-related thrombosis. Patients will be examined in the supine position. Doppler ultrasound will be used to evaluate the internal jugular (IJV), subclavian (SCV), femoral (FV), or axillary vein on the same side as the IJV. Ultrasound criteria for the diagnosis of VCRT will require the presence of at least two of the following: intravenous echogenic filling defect, lack of compression of the vein, or abnormal color Doppler pattern. The thrombosis size will be evaluated as follows: In the axial plane, the section with the largest thrombosis area will be selected to measure the maximum and minimum distances, and the maximum distance will be defined as the diameter of the thrombosis. In the longitudinal plane, the length of the thrombosis will be measured. The ultrasound will be performed by an experienced specialist who is competent in bedside ultrasound and is not responsible for patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patient (18-80 years old)
  • No hematological disease causing hypercoagulability
  • Not receiving anticoagulant/antifibrinolytic medications at the therapy dose
  • The vascular structure can be visualized with US
  • No thrombosis in the US control before catheter placement
  • The catheter is not inserted for renal replacement therapy

Exclusion Criteria:

  • Presence of renal failure
  • Pediatric patients
  • Presence of hematological malignancy
  • Inadequate US imaging

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Catheter-related thrombosis in oncologic patients after major surgery
Cancer patients who will receive central venous catheter
Diagnostic test: Ultrasonographic evaluation of vascular catheter-related thrombosis after oncological surgery.
In patients who will undergo oncological surgery and have a central venous catheter, the presence of thrombosis, its duration of occurrence and its dimensions will be evaluated by ultrasonography.
Active Comparator: Catheter-related thrombosis in non-oncologic patients after major surgery
Patients without known cancer who will receive a central venous catheter
Diagnostic test: Ultrasonographic evaluation of vascular catheter-related thrombosis after non-oncological surgery.
In patients who will undergo non-oncological surgery and have a central venous catheter, the presence of thrombosis, its duration of occurrence and its dimensions will be evaluated by ultrasonography.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of catheter related vascular thrombosis after surgery
Time Frame: The vascular catheter will be monitored for the duration of its stay, at least 10 days if possible.
The incidence of vascular catheter-related thrombus in oncologic and non-oncologic surgery patients.
The vascular catheter will be monitored for the duration of its stay, at least 10 days if possible.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time from vascular catheter placement to the onset of thrombus formation
Time Frame: Daily assessment until vascular catheter removal, if possible for at least 10 days postoperatively
The time from the placement of the vascular catheter until the first detection of thrombus according to US criteria
Daily assessment until vascular catheter removal, if possible for at least 10 days postoperatively
Relationship between demographic characteristics of patients (age, gender and additional diseases) recorded on the preoperative anesthesia assessment form and vascular catheter-related thrombosis
Time Frame: From preoperative anesthesia assessment to postoperative day 10
Comparison of patients according to gender, age and additional diseases
From preoperative anesthesia assessment to postoperative day 10
Daily changes in thrombus area (cm2) from the diagnosis of vascular catheter-related thrombus to catheter removal or patient discharge
Time Frame: Daily assessment until vascular catheter removal, if possible for at least 10 days postoperatively
Daily US evaluation of the area in patients with catheter related thrombus formation
Daily assessment until vascular catheter removal, if possible for at least 10 days postoperatively
The incidence of severe complications such as pulmonary embolism, cerebrovascular disease or acute coronary ischemia that may occur due to vascular catheter-related thrombosis
Time Frame: Daily assessment until vascular catheter removal, if possible for at least 30 days postoperatively
Evaluation for the development of pulmonary embolism, cerebrovascular occlusions and acute coronary ischemia
Daily assessment until vascular catheter removal, if possible for at least 30 days postoperatively
Lenght of stay at hospital/ICU and mortality
Time Frame: From date of surgery until the date of discharge of patient or date of death from any cause, whichever came first, assessed up to 10 weeks
To compare the length of hospital stay of patients with and without catheter-related thrombus and to determine mortality rates.
From date of surgery until the date of discharge of patient or date of death from any cause, whichever came first, assessed up to 10 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mersin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Levent Özdemir, Mersin University, Faculty of Medicine, Mersin, Turkiye

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023/555

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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