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

NCT05966909 | Completed

• 1 other identifier: THROMBPICC
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter Related Complication

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Catheter related thrombosis

  Symptomatic and asymptomatic upper extremities thrombosis

  1 month and 3 months from baseline

Secondary Outcomes (1)

• PICC vs PICC-PORT

  1 month and 3 months from baseline

Study Arms (1)

Solid cancer patients

Patients with solid cancer who underwent the placement of a PICC or PICC-PORT for chemotherapy.

Diagnostic Test: Doppler Ultrasound

Interventions

Doppler Ultrasound DIAGNOSTIC_TEST

Ultrasound diagnosi of asymptomatic and symptomatic upper extremities vein thrombosis

Solid cancer patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with solid cancer undergoing chemotherapy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata

Verona, 37134, Italy

Location

MeSH Terms

Interventions

Ultrasonography, Doppler

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mattia Cominacini, MD

  Azienda Ospedaliera Universitaria Integrata Verona

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)