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

Catheter Related Complication Clinical Trial

Official title:

Asymptomatic PICC-related Thrombosis in Cancer Patients: a Prospective Cohort Study of an Ultrasound-guided Approach.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05966909
• Other study ID #: THROMBPICC
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2023
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Catheter Related Complication
• Thrombosis

Intervention

Diagnostic Test:
• Doppler Ultrasound
Ultrasound diagnosi of asymptomatic and symptomatic upper extremities vein thrombosis

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Integrata	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catheter related thrombosis	Symptomatic and asymptomatic upper extremities thrombosis	1 month and 3 months from baseline
Secondary	PICC vs PICC-PORT	Risk factors associated with Catheter related Thrombosis	1 month and 3 months from baseline