Vascular Access in Hematological Patients - PICC Versus CVC
1 other identifier
interventional
88
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 13, 2015
CompletedFirst Posted
Study publicly available on registry
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedApril 10, 2018
April 1, 2018
2.7 years
March 13, 2015
April 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Catheter-related bloodstream infections
1\. Cumulative incidence of catheter-related (CR)-major complications: catheter-related bloodstream infections and CR-deep-vein thrombosis.
1 year
Secondary Outcomes (1)
Other complications
1 year
Study Arms (2)
Peripherally inserted central catheters
EXPERIMENTALPeripherally inserted central catheters (PICCs) - Most commonly used vascular access in hematological patients - Randomization between CICCs and PICCs
Centrally inserted central catheter
ACTIVE COMPARATORCentrally inserted central catheter (CICCs) - New vascular access, with the aim to reduce the complications - Randomization between CICCs and PICCs
Interventions
Randomization between two well established clinical routine vascular access devices
Randomization between two well established clinical routine vascular access devices
Eligibility Criteria
You may qualify if:
- Age \>18 yrs
- Newly diagnosed AML
- Suspected survival \> 4 weeks
- Need of central venous access \>4 weeks
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prof Marco Picardi - Hematology - AOU FEDERICO II
Napoli, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Picardi, Prof
Hematology - AOU Federico II - Napoli - Italy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
March 13, 2015
First Posted
April 1, 2015
Study Start
February 1, 2015
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
April 10, 2018
Record last verified: 2018-04