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

NCT ID: NCT05966909

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-12-31

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.

Conditions

Catheter Related Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Solid cancer patients

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

Doppler Ultrasound

Intervention Type: DIAGNOSTIC_TEST

Ultrasound diagnosi of asymptomatic and symptomatic upper extremities vein thrombosis

Interventions

Doppler Ultrasound

Ultrasound diagnosi of asymptomatic and symptomatic upper extremities vein thrombosis

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: lead

Responsible Party

Luca Giuseppe Dalle Carbonare

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mattia Cominacini, MD

Role: STUDY_DIRECTOR

Azienda Ospedaliera Universitaria Integrata Verona

Locations

Azienda Ospedaliera Universitaria Integrata

Verona, , Italy

Countries

Italy

Other Identifiers

THROMBPICC

Identifier Type: -

Identifier Source: org_study_id