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Incidence and Clinical Progression of Asymptomatic PICC-Related Thrombosis in Solid Cancer Patients

Asymptomatic PICC-related Thrombosis in Cancer Patients: a Prospective Cohort Study of an Ultrasound-guided Approach.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05966909
Enrollment
120
Registered
2023-08-01
Start date
2020-01-01
Completion date
2022-12-31
Last updated
2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Related Complication

Keywords

Catheter-related thrombosis, Peripherally inserted central catheter-ports, Cancer associated thrombosis, Upper extremities vein thrombosis

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.

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.

Interventions

DIAGNOSTIC_TESTDoppler Ultrasound

Ultrasound diagnosi of asymptomatic and symptomatic upper extremities vein thrombosis

Sponsors

Azienda Ospedaliera Universitaria Integrata Verona
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years

Inclusion criteria

* patients with: 1. a documented active malignancy; 2. PICC or PORT placement for systemic chemotherapy;

Exclusion criteria

* patients with: 1. a communication disorder; 2. contraindications to anticoagulation therapy; 3. hematopathy; 4. expected survival of less than one month; 5. were lost to follow-up.

Design outcomes

Primary

MeasureTime frameDescription
Catheter related thrombosis1 month and 3 months from baselineSymptomatic and asymptomatic upper extremities thrombosis

Secondary

MeasureTime frameDescription
PICC vs PICC-PORT1 month and 3 months from baselineRisk factors associated with Catheter related Thrombosis

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026