Vascular Access in Hematological Patients - PICC Versus CVC

Vascular Access in Hematological Patients - PICC Versus CVC in a Phase IV Randomized Controlled Trial

The use of peripherally inserted central catheters (PICCs) represents a major advance for hematological patients, enabling the effective delivery of chemotherapy and/or blood products particularly for prolonged infusions or in situation of difficult venous access. In modern medical practice their use has increased rapidly for several reasons, including ease of insertion, many uses (e.g., drug administration and venous access), perceived safety, and cost-effectiveness compared with centrally inserted central catheters (CICCs).

Study Overview

• Status: Completed
• Conditions: Vascular Access Complication
• Intervention / Treatment: Device: Peripherally inserted central catheters (PICCs); Device: Centrally inserted central catheters (CICCs)

Detailed Description

The use of peripherally inserted central catheters (PICCs) represents a major advance for hematological patients, enabling the effective delivery of chemotherapy and/or blood products particularly for prolonged infusions or in situation of difficult venous access. In modern medical practice their use has increased rapidly for several reasons, including ease of insertion, many uses (e.g., drug administration and venous access), perceived safety, and costeffectiveness compared with centrally inserted central catheters (CICCs). Despite these benefits, PICCs are associated with deep vein thrombosis of the arm and pulmonary embolism. These complications, which are often called venous thromboembolism, are important because they not only complicate and interrupt treatment, but also increase cost, morbidity and mortality. Despite this effect, the burden and risk of PICC-related venous thromboembolism is uncertain and clinicians have scarce evidence on which to base choice of vascular access. Evidence to choose one vascular access over the other is lacking in literature, in particular for patients affected by haematological malignancies, in which chemotherapy is more likely to cause myelosuppression, with a major risk of bloodstream infections. Furthermore, the precise incidence and the risk of PICC-related venous thromboembolism relative to that of other CICCs is unknown. An understanding of this risk in the context of growing PICC use is an important cost and patients safety questions. Up to now, no systematic review has been done to investigate these questions.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy
    • Prof Marco Picardi - Hematology - AOU FEDERICO II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >18 yrs
• Newly diagnosed AML
• Suspected survival > 4 weeks
• Need of central venous access >4 weeks

Exclusion Criteria:

• Ongoing uncontrolled systemic infection
• Presence of significant thrombosis/stenosis in arm or central veins
• Diagnosis of another cancer within 12 months before AML onset
• any evidence of clinical conditions indicating unability to receive intent-to- cure chemotherapy
• Unability to communicate and/or to sign informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peripherally inserted central catheters; Peripherally inserted central catheters (PICCs) - Most commonly used vascular access in hematological patients - Randomization between CICCs and PICCs	Device: Peripherally inserted central catheters (PICCs); Randomization between two well established clinical routine vascular access devices
Active Comparator: Centrally inserted central catheter; Centrally inserted central catheter (CICCs) - New vascular access, with the aim to reduce the complications - Randomization between CICCs and PICCs	Device: Centrally inserted central catheters (CICCs); Randomization between two well established clinical routine vascular access devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter-related bloodstream infections	1. Cumulative incidence of catheter-related (CR)-major complications: catheter-related bloodstream infections and CR-deep-vein thrombosis.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other complications	2. Occurrence of complications associated with catheter positioning (serious bleeding, arterial puncture and/or pneumothorax), catheter malfunctions (dislocation, occlusion and/or rupture), catheter removals and 30-days overall mortality.	1 year

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Marco Picardi, Prof, Hematology - AOU Federico II - Napoli - Italy

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: March 13, 2015
• First Submitted That Met QC Criteria: March 28, 2015
• First Posted (Estimate): April 1, 2015

Study Record Updates

• Last Update Posted (Actual): April 10, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: PICC; CICC; BLOODSTREAM INFECTIONS; VASCULAR ACCESS; DEEP VEIN THROMBOSIS
• Other Study ID Numbers: HEM-FEDII-PICC-001