Vascular Access in Hematological Patients - PICC Versus CVC

NCT ID: NCT02405728

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-10-31

Brief Summary

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).

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.

Conditions

Vascular Access Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Peripherally inserted central catheters

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

Group Type: EXPERIMENTAL

Peripherally inserted central catheters (PICCs)

Intervention Type: DEVICE

Randomization between two well established clinical routine vascular access devices

Centrally inserted central catheter

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

Group Type: ACTIVE_COMPARATOR

Centrally inserted central catheters (CICCs)

Intervention Type: DEVICE

Randomization between two well established clinical routine vascular access devices

Interventions

Centrally inserted central catheters (CICCs)

Randomization between two well established clinical routine vascular access devices

Intervention Type: DEVICE

Peripherally inserted central catheters (PICCs)

Randomization between two well established clinical routine vascular access devices

Intervention Type: DEVICE

Eligibility Criteria

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

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

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Marco Picardi

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Picardi, Prof

Role: PRINCIPAL_INVESTIGATOR

Hematology - AOU Federico II - Napoli - Italy

Locations

Prof Marco Picardi - Hematology - AOU FEDERICO II

Napoli, , Italy

Countries

Italy

Other Identifiers

HEM-FEDII-PICC-001

Identifier Type: -

Identifier Source: org_study_id