Clinical trial NCT02405728: Vascular Access in Hematological Patients - PICC Versus CVC
Official title: Vascular Access in Hematological Patients - PICC Versus CVC in a Phase IV Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Access Complication
Keywords: PICC
BLOODSTREAM INFECTIONS
VASCULAR ACCESS
DEEP VEIN THROMBOSIS
CICC
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Catheter-related bloodstream infections
timeFrame: 1 year
Secondary outcomes:
measure: Other complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Prof Marco Picardi - Hematology - AOU FEDERICO II
Study officials:
affiliation: Hematology - AOU Federico II - Napoli - Italy
name: Marco Picardi, Prof
role: PRINCIPAL_INVESTIGATOR
References: