Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635551
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Comparison of Vascular Catheter-Related Thrombosis and Risk Factors After Oncologic and Non-Oncologic Major Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Vascular Catheter-Related Thrombosis and Risk Factors Using Daily Bedside Ultrasonography After Oncologic and Non-Oncologic Major Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None