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

NCT06635551 | Recruiting

• 1 other identifier: 2023/555
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Thromboses, Venous; Surgery; Catheter Related Complication

Keywords

Central Venous Catheters; Venous Thrombosis; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Incidence of catheter related vascular thrombosis after surgery

  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 Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Catheter-related thrombosis in oncologic patients after major surgery

EXPERIMENTAL

Cancer patients who will receive central venous catheter

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

Diagnostic Test: Ultrasonographic evaluation of vascular catheter-related thrombosis after non-oncological surgery.

Interventions

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.

Catheter-related thrombosis in oncologic patients after major surgery

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.

Catheter-related thrombosis in non-oncologic patients after major surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, Yenişehir, 33343, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 29754308 BACKGROUND

• Wu 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.

  PMID: 36892598 BACKGROUND

• Debourdeau 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.

  PMID: 34363736 BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Levent Özdemir

  Mersin University, Faculty of Medicine, Mersin, Turkiye

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Levent Özdemir

CONTACT

+905324867051; leventozdemirmd@gmail.com

Nurcan Doruk

CONTACT

+905323767467; nurcandoruk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: October 10, 2024
• Study Start: December 4, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)