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Vascular Access in Hematological Patients - PICC Versus CVC

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02405728
Enrollment
88
Registered
2015-04-01
Start date
2015-02-28
Completion date
2017-10-31
Last updated
2018-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Access Complication

Keywords

PICC, BLOODSTREAM INFECTIONS, VASCULAR ACCESS, DEEP VEIN THROMBOSIS, CICC

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.

Interventions

DEVICECentrally inserted central catheters (CICCs)

Randomization between two well established clinical routine vascular access devices

DEVICEPeripherally inserted central catheters (PICCs)

Randomization between two well established clinical routine vascular access devices

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Catheter-related bloodstream infections1 year1\. Cumulative incidence of catheter-related (CR)-major complications: catheter-related bloodstream infections and CR-deep-vein thrombosis.

Secondary

MeasureTime frameDescription
Other complications1 year2\. 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026