Clinical trial NCT05966909: Incidence and Clinical Progression of Asymptomatic PICC-Related Thrombosis in Solid Cancer Patients
Official title: Asymptomatic PICC-related Thrombosis in Cancer Patients: a Prospective Cohort Study of an Ultrasound-guided Approach.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Catheter Related Complication
Keywords: Catheter-related thrombosis
Peripherally inserted central catheter-ports
Cancer associated thrombosis
Upper extremities vein thrombosis
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with solid cancer undergoing chemotherapy

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Catheter related thrombosis
timeFrame: 1 month and 3 months from baseline
Secondary outcomes:
measure: PICC vs PICC-PORT
timeFrame: 1 month and 3 months from baseline
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata
Study officials:
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: Mattia Cominacini, MD
role: STUDY_DIRECTOR
References: