Skip to main content
OpenTrials
Completed

NCT Number: NCT02405728

Vascular Access in Hematological Patients - PICC Versus CVC

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof Marco Picardi - Hematology - AOU FEDERICO II

Naples, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Centrally inserted central catheters (CICCs)

Device

Randomization between two well established clinical routine vascular access devices

Peripherally inserted central catheters (PICCs)

Device

Randomization between two well established clinical routine vascular access devices

Primary outcomes

  1. Catheter-related bloodstream infections

    Time frame: 1 year

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

Secondary outcomes

  1. Other complications

    Time frame: 1 year

    • 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.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 1, 2015
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.