Incidence and Clinical Progression of Asymptomatic PICC-Related Thrombosis in Solid Cancer Patients
Study Details
Study Description
Brief Summary
In this prospective cohort study, the investigators evaluated the incidence of superficial vein thrombosis, deep vein thrombosis, and fibroblastic sleeve formation in solid cancer patients undergoing chemotherapy. The study aimed to shed light on the clinical progression of venous thrombosis in cancer patients with central venous catheters, with a particular focus on certain cancer types associated with a higher risk of venous thromboembolism (VTE).
The investigators believe that such findings hold significant clinical relevance as a substantial portion of the study population was affected by pancreatic cancer, a cancer type known to carry a high risk of thrombotic events. This research adds valuable insights into understanding asymptomatic PICC-related thrombosis in this specific subgroup of cancer patients, which can aid in developing effective management strategies for venous access in this challenging population.
The study employed an ultrasound-guided approach for follow-up at 30 and 90 days after catheter insertion, enabling us to detect and treat asymptomatic PICC-VTE in a timely manner. Identifying independent risk factors for catheter-related thrombosis, including age and cancer type, has further enhanced the clinical applicability of our findings.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Managing venous access in cancer patients is challenging, and peripherally inserted central catheter-ports (PICC-ports) have emerged as a promising option for safety and efficacy. However, understanding the clinical progression of venous thrombosis in cancer patients with central venous catheters remains limited, especially in certain cancer types associated with a higher risk of venous thromboembolism (VTE).
In this prospective cohort study of solid cancer patients receiving chemotherapy, the investigators will evaluate the incidence of superficial vein thrombosis, deep vein thrombosis, and fibroblastic sleeve formation through ultrasound follow-up at 30 and 90 days after catheter insertion. The investigators will analyze clinical factors associated with PICC-related VTE (PICC-VTE) and compare incidence rates between PICC-ports and traditional PICCs.
Ultrasound follow-up is valuable for detecting asymptomatic PICC-VTE, enabling timely and effective initiation of therapy, especially in elderly patients and those with high-risk thrombotic cancers.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Solid cancer patients Patients with solid cancer who underwent the placement of a PICC or PICC-PORT for chemotherapy. |
Diagnostic Test: Doppler Ultrasound
Ultrasound diagnosi of asymptomatic and symptomatic upper extremities vein thrombosis
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Outcome Measures
Primary Outcome Measures
- Catheter related thrombosis [1 month and 3 months from baseline]
Symptomatic and asymptomatic upper extremities thrombosis
Secondary Outcome Measures
- PICC vs PICC-PORT [1 month and 3 months from baseline]
Risk factors associated with Catheter related Thrombosis
Eligibility Criteria
Criteria
Inclusion Criteria:
- patients with:
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a documented active malignancy;
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PICC or PORT placement for systemic chemotherapy;
Exclusion Criteria:
- patients with:
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a communication disorder;
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contraindications to anticoagulation therapy;
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hematopathy;
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expected survival of less than one month;
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were lost to follow-up.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azienda Ospedaliera Universitaria Integrata | Verona | Italy | 37134 |
Sponsors and Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona
Investigators
- Study Director: Mattia Cominacini, MD, Azienda Ospedaliera Universitaria Integrata Verona
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- THROMBPICC