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Clinical Trials/NCT02405728
NCT02405728
Completed
N/A

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

Federico II University1 site in 1 country88 target enrollmentFebruary 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Vascular Access Complication
Sponsor
Federico II University
Enrollment
88
Locations
1
Primary Endpoint
Catheter-related bloodstream infections
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
October 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federico II University
Responsible Party
Principal Investigator
Principal Investigator

Marco Picardi

Prof

Federico II University

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

Outcomes

Primary Outcomes

Catheter-related bloodstream infections

Time Frame: 1 year

1. Cumulative incidence of catheter-related (CR)-major complications: catheter-related bloodstream infections and CR-deep-vein thrombosis.

Secondary Outcomes

  • Other complications(1 year)

Study Sites (1)

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