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Completed

NCT Number: NCT05966909

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Universitaria Integrata

Verona, 37134, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with:
  • a documented active malignancy;
  • PICC or PORT placement for systemic chemotherapy;

Exclusion criteria

  • patients with:
  • a communication disorder;
  • contraindications to anticoagulation therapy;
  • hematopathy;
  • expected survival of less than one month;
  • were lost to follow-up.

Treatment and study plan

Doppler Ultrasound

Diagnostic Test

Ultrasound diagnosi of asymptomatic and symptomatic upper extremities vein thrombosis

Primary outcomes

  1. Catheter related thrombosis

    Time frame: 1 month and 3 months from baseline

    Symptomatic and asymptomatic upper extremities thrombosis

Secondary outcomes

  1. PICC vs PICC-PORT

    Time frame: 1 month and 3 months from baseline

    Risk factors associated with Catheter related Thrombosis

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 1, 2023
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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