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

Not Applicable

Recruiting

• Conditions: Catheter Related Complication; Thromboses, Venous; Surgery
• Interventions: Diagnostic Test: Ultrasonographic evaluation of vascular catheter-related thrombosis after oncological surgery.; Diagnostic Test: Ultrasonographic evaluation of vascular catheter-related thrombosis after non-oncological surgery.

• Registration Number: NCT06635551
• Lead Sponsor: Mersin University

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 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 Timeline

• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-10
• Status Verified: 2024-12
• Study Start: 2024-12-04
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter-related thrombosis in oncologic patients after major surgery	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	Ultrasonographic evaluation of vascular catheter-related thrombosis after non-oncological surgery.	Patients without known cancer who will receive a central venous catheter

Primary Outcome Measures

Name	Time	Method
Incidence of catheter related vascular thrombosis after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Time from vascular catheter placement to the onset of thrombus formation	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
Relationship between demographic characteristics of patients (age, gender and additional diseases) recorded on the preoperative anesthesia assessment form and vascular catheter-related thrombosis	From preoperative anesthesia assessment to postoperative day 10	Comparison of patients according to gender, age and additional diseases
Daily changes in thrombus area (cm2) from the diagnosis of vascular catheter-related thrombus to catheter removal or patient discharge	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
The incidence of severe complications such as pulmonary embolism, cerebrovascular disease or acute coronary ischemia that may occur due to vascular catheter-related thrombosis	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
Lenght of stay at hospital/ICU and mortality	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.

Trial Locations

Locations (1)

Mersin University; 🇹🇷 Mersin, Yenişehir, Turkey