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.

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.

Study Overview

• Status: Completed
• Conditions: Catheter Related Complication
• Intervention / Treatment: Diagnostic test: Doppler Ultrasound

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37134
    • Azienda Ospedaliera Universitaria Integrata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with solid cancer undergoing chemotherapy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter related thrombosis	Symptomatic and asymptomatic upper extremities thrombosis	1 month and 3 months from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PICC vs PICC-PORT	Risk factors associated with Catheter related Thrombosis	1 month and 3 months from baseline

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
• Investigators: Study Director: Mattia Cominacini, MD, Azienda Ospedaliera Universitaria Integrata Verona

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Catheter-related thrombosis; Peripherally inserted central catheter-ports; Cancer associated thrombosis; Upper extremities vein thrombosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: THROMBPICC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No