Catheter Related ComplicationNCT06635551
Comparison of Vascular Catheter-Related Thrombosis and Risk Factors After Oncologic and Non-Oncologic Major Surgery
A study testing Ultrasonographic evaluation of vascular catheter-related thrombosis after oncological surgery. and Ultrasonographic evaluation of vascular catheter-related thrombosis after non-oncological surgery. in people with Catheter Related Complication and Thromboses, Venous, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Catheter Related Complication, Thromboses, Venous, Surgery
- What is being tested?
- Ultrasonographic evaluation of vascular catheter-related thrombosis after oncological surgery. and Ultrasonographic evaluation of vascular catheter-related thrombosis after non-oncological surgery.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Dec 2024to 28 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of renal failure
- Pediatric patients
- Presence of hematological malignancy
- Inadequate US imaging
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Catheter Related Complication, Thromboses, Venous, Surgery
- Being tested
- Ultrasonographic evaluation of vascular catheter-related thrombosis after oncological surgery., Ultrasonographic evaluation of vascular catheter-related thrombosis after non-oncological surgery.
- Keywords
- Central Venous Catheters, Venous Thrombosis, Ultrasonography
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic evaluation of vascular catheter-related thrombosis after oncological surgery.Diagnostic test
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.
Ultrasonographic evaluation of vascular catheter-related thrombosis after non-oncological surgery.Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Catheter-related thrombosis in oncologic patients after major surgery | Experimental | Cancer patients who will receive central venous catheter Receives: Diagnostic Test: Ultrasonographic evaluation of vascular catheter-related thrombosis after oncological surgery. |
| Catheter-related thrombosis in non-oncologic patients after major surgery | Active comparator | Patients without known cancer who will receive a central venous catheter Receives: Diagnostic Test: Ultrasonographic evaluation of vascular catheter-related thrombosis after non-oncological surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of catheter related vascular thrombosis after surgery
The incidence of vascular catheter-related thrombus in oncologic and non-oncologic surgery patients.
Measured: The vascular catheter will be monitored for the duration of its stay, at least 10 days if possible.
Secondary outcomes (5)
Time from vascular catheter placement to the onset of thrombus formation
The time from the placement of the vascular catheter until the first detection of thrombus according to US criteria
Measured: 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
Comparison of patients according to gender, age and additional diseases
Measured: 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
Daily US evaluation of the area in patients with catheter related thrombus formation
Measured: 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
Evaluation for the development of pulmonary embolism, cerebrovascular occlusions and acute coronary ischemia
Measured: Daily assessment until vascular catheter removal, if possible for at least 30 days postoperatively
Lenght of stay at hospital/ICU and mortality
To compare the length of hospital stay of patients with and without catheter-related thrombus and to determine mortality rates.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start4 Dec 2024
- Primary completion16 Apr 2026
- Study completion28 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Catheter Related ComplicationStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assistant Prof Levent Özdemir, M.D., Mersin University
- Investigators
- Levent Özdemir, Principal investigator, Mersin University, Faculty of Medicine, Mersin, Turkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635551
- Sponsor's protocol ID
- 2023/555
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Timsit JF, Rupp M, Bouza E, Chopra V, Karpanen T, Laupland K, Lisboa T, Mermel L, Mimoz O, Parienti JJ, Poulakou G, Souweine B, Zingg W. A state of the art review on optimal practices to prevent, recognize, and manage complications associated with intravascular devices in the critically ill. Intensive Care Med. 2018 Jun;44(6):742-759. doi: 10.1007/s00134-018-5212-y. Epub 2018 May 12.
PubMed 29754308Wu C, Zhang M, Gu W, Wang C, Zheng X, Zhang J, Zhang X, Lv S, He X, Shen X, Wei W, Wang G, Lu Y, Chen Q, Shan R, Wang L, Wu F, Shen T, Shao X, Cai J, Tao F, Cai H, Lu Q; Study Group of Central Venous Catheter-related Thrombosis. Daily point-of-care ultrasound-assessment of central venous catheter-related thrombosis in critically ill patients: a prospective multicenter study. Intensive Care Med. 2023 Apr;49(4):401-410. doi: 10.1007/s00134-023-07006-x. Epub 2023 Mar 9.
PubMed 36892598Debourdeau P, Lamblin A, Debourdeau T, Marcy PY, Vazquez L. Venous thromboembolism associated with central venous catheters in patients with cancer: From pathophysiology to thromboprophylaxis, areas for future studies. J Thromb Haemost. 2021 Nov;19(11):2659-2673. doi: 10.1111/jth.15487. Epub 2021 Aug 26.
PubMed 34363736
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vascular Catheter-Related Thrombosis and Risk Factors Using Daily Bedside Ultrasonography After Oncologic and Non-Oncologic Major Surgery
- ClinicalTrials.gov ID
- NCT06635551
- Acronym / sponsor ID
- 2023/555
- Conditions
- Catheter Related Complication, Thromboses, Venous, Surgery
- Keywords
- Central Venous Catheters, Venous Thrombosis, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 28 Aug 2026 (actual)
- First posted
- 10 Oct 2024 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter-related thrombosis in oncologic patients after major surgery | Experimental | Diagnostic Test: Ultrasonographic evaluation of vascular catheter-related thrombosis after oncological surgery.Cancer patients who will receive central venous catheter |
| Catheter-related thrombosis in non-oncologic patients after major surgery | Active comparator | Diagnostic Test: Ultrasonographic evaluation of vascular catheter-related thrombosis after non-oncological surgery.Patients without known cancer who will receive a central venous catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Presence of renal failure
- Pediatric patients
- Presence of hematological malignancy
- Inadequate US imaging
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 |
|---|---|---|
| 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. | Diagnostic test | Catheter-related thrombosis in oncologic patients after major surgery |
| 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. | Diagnostic test | Catheter-related thrombosis in non-oncologic patients after major surgery |
Primary outcome
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 29754308Timsit JF, Rupp M, Bouza E, Chopra V, Karpanen T, Laupland K, Lisboa T, Mermel L, Mimoz O, Parienti JJ, Poulakou G, Souweine B, Zingg W. A state of the art review on optimal practices to prevent, recognize, and manage complications associated with intravascular devices in the critically ill. Intensive Care Med. 2018 Jun;44(6):742-759. doi: 10.1007/s00134-018-5212-y. Epub 2018 May 12.
- Background: PubMed 36892598Wu C, Zhang M, Gu W, Wang C, Zheng X, Zhang J, Zhang X, Lv S, He X, Shen X, Wei W, Wang G, Lu Y, Chen Q, Shan R, Wang L, Wu F, Shen T, Shao X, Cai J, Tao F, Cai H, Lu Q; Study Group of Central Venous Catheter-related Thrombosis. Daily point-of-care ultrasound-assessment of central venous catheter-related thrombosis in critically ill patients: a prospective multicenter study. Intensive Care Med. 2023 Apr;49(4):401-410. doi: 10.1007/s00134-023-07006-x. Epub 2023 Mar 9.
- Background: PubMed 34363736Debourdeau P, Lamblin A, Debourdeau T, Marcy PY, Vazquez L. Venous thromboembolism associated with central venous catheters in patients with cancer: From pathophysiology to thromboprophylaxis, areas for future studies. J Thromb Haemost. 2021 Nov;19(11):2659-2673. doi: 10.1111/jth.15487. Epub 2021 Aug 26.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Levent Özdemir principal investigator
Mersin University, Faculty of Medicine, Mersin, Turkiye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonographic evaluation of vascular catheter-related thrombosis after oncological surgery. and Ultrasonographic evaluation of vascular catheter-related thrombosis after non-oncological surgery. in people with Catheter Related Complication and Thromboses, Venous, run by Mersin University at 1 site in Turkey (Türkiye).
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 vascular thrombosis after surgery (time frame: The vascular catheter will be monitored for the duration of its stay, at least 10 days if possible.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06635551, which also lists 3 linked publications.
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 13 Oct 2026.