Vascular Access in Hematological Patients - PICC Versus CVC

Federico II University

Status: Completed

Conditions: Vascular Access Complication

Treatments: Device: Centrally inserted central catheters (CICCs); Device: Peripherally inserted central catheters (PICCs)

Study type: Interventional

Funder types: Other

Identifiers

NCT02405728

HEM-FEDII-PICC-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Peripherally inserted central catheters

Experimental group

Description:

Peripherally inserted central catheters (PICCs) - Most commonly used vascular access in hematological patients - Randomization between CICCs and PICCs

Treatment:

Device: Peripherally inserted central catheters (PICCs)

Centrally inserted central catheter

Active Comparator group

Description:

Centrally inserted central catheter (CICCs) - New vascular access, with the aim to reduce the complications - Randomization between CICCs and PICCs

Treatment:

Device: Centrally inserted central catheters (CICCs)