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

Completed

• Conditions: Catheter Related Complication
• Interventions: Diagnostic Test: Doppler Ultrasound

• Registration Number: NCT05966909
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Study First Submitted: 2023-07-21
• Study First Submitted QC: 2023-07-21
• Status Verified: 2023-08
• Study First Posted: 2023-08-01
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Solid cancer patients	Doppler Ultrasound	Patients with solid cancer who underwent the placement of a PICC or PICC-PORT for chemotherapy.

Primary Outcome Measures

Name	Time	Method
Catheter related thrombosis	1 month and 3 months from baseline	Symptomatic and asymptomatic upper extremities thrombosis

Secondary Outcome Measures

Name	Time	Method
PICC vs PICC-PORT	1 month and 3 months from baseline	Risk factors associated with Catheter related Thrombosis

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria Integrata; 🇮🇹 Verona, Italy