Patients Indicated for a PICC for Any Medical Condition
Conditions
Brief summary
The main purpose of this study is to confirm whether the AngioDynamics BioFlo™ Peripherally Inserted Central Catheter (PICC) is associated with less formation of blood clots compared to another commercially available PICC.
Detailed description
Purpose: To investigate whether the BioFlo™ PICC will be associated with a reduced incidence of catheter-related venous thrombosis (including both symptomatic and asymptomatic) compared to another commercially available PICC: the Bard® PowerPICC SOLO2® Design: This is a randomized, multi-center clinical study. The study is designed as a two-arm prospectively controlled trial. Participants will be randomly assigned to either the study or control catheter using a 1:1 schema. Enrollment: Four hundred sixteen (416) patients will be enrolled at four (4) to eight (8) study sites in order to obtain 354 evaluable patients. Study Objectives: The primary objective of this study is to investigate the incidence of catheter-related venous thrombosis in patients receiving either the 5 Fr BioFlo™ PICC catheter or the control catheter, i.e., the 5 Fr Dual-Lumen PowerPICC SOLO2® catheter. Secondary objectives of this study are to investigate: * Incidence of other catheter-related complications, inclusive of catheter occlusion, catheter-related infection, technical failures, and premature catheter removals * Incidence of catheter occlusion (independently from other catheter-related complications) Additionally, economic outcomes with respect to medical resource utilization requirements will be compared between the two catheter groups (at US sites only).
Interventions
DEVICEBioFlo™ Peripherally Inserted Central Catheter (PICC)
DEVICEBard® Dual-Lumen PowerPICC SOLO2®
Sponsors
Angiodynamics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is indicated for a PICC based on institutional practices 2. Is ≥ 18 years of age 3. Is expected to require use of a PICC for a minimum of 10 days 4. Has normal findings on initial ultrasonography (complete Ultrasound Checklist) 5. Vein used for PICC placement must be a minimum of 5mm in diameter 6. Is able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study (or has the ICF signed by the patient's legal representative)
Exclusion criteria
1. Anticipates or has presence of dialysis grafts or other ipsilateral intraluminal devices, including pacemakers (with the exception of peripheral IV catheters) 2. Has current or anticipated hematologic derangements, including: * thrombocytopenia * history of heparin-induced thrombocytopenia * coagulopathy (International Normalized Ratio 2.5 or greater) * established diagnosis of hypercoagulable syndrome (e.g., protein C and S deficiency, anti-phospholipid antibody or polycythemia) or requires systemic therapeutic anticoagulation (Note: The following prophylactic treatments are allowed: subcutaneous heparin or enoxaparin sodium injection, and concomitant use of platelet aggregation inhibitors, e.g., Plavix/Ticlid/aspirin) 3. Has central veno-occlusive disease 4. Has history of previous catheter-related thrombosis 5. Has arm identified for catheterization that exhibits any of the following (and the contralateral arm is also unsuitable for PICC placement based on the same criteria): * Current (or prior history of) venous thrombosis in all or any portion of the vein where the catheter is expected to reside * Conditions that impede venous return from the extremity (such as paralysis or lymphedema after mastectomy) * Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site * Anatomical distortions from surgery, injury or trauma (e.g., orthopedic conditions such as compound fractures requiring reconstructive procedures) * Anatomical irregularities (structural, vascular, neurological) which may compromise catheter insertion or catheter care procedures in the involved extremity (e.g., reflex sympathetic dystrophy) 6. Is pregnant or lactating 7. Has been previously enrolled in this clinical study, or is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Catheter-related Venous Thrombosis as Confirmed by Diagnostic Ultrasound | 10 (+/-3) days and any time there is clinically suspected venous thrombosis (as per standard of care) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Other Catheter-related Complications | Up to 30 days post-insertion | Secondary objectives of this study are to investigate: * Incidence of other catheter-related complications, inclusive of catheter occlusion, catheter-related infection, technical failures, and premature catheter removals * Incidence of catheter occlusion (independently from other catheter-related complications) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medical Resource Utilization Data Analysis | Up to 30 days post-insertion | Economic outcomes with respect to medical resource utilization requirements will be compared between the two PICC groups. Only data from US sites will be used for this analysis. |
Countries
Canada, Switzerland, United States
Participant flow
Pre-assignment details
The study was prematurely terminated and the PI was blinded to study data, and therefore never had access to the data and does not have any information that might help us locate it. Additionally, AngioDynamics' IT team ran a thorough search for any data related to this study and no results were found.
Participants by arm
| Arm | Count |
|---|---|
| BioFlo™ PICC BioFlo™ Peripherally Inserted Central Catheter (PICC) | 0 |
| Bard® PowerPICC SOLO2® Bard® Dual-Lumen PowerPICC SOLO2® | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment Canada | — participants |
| Region of Enrollment Switzerland | — participants |
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Incidence of Catheter-related Venous Thrombosis as Confirmed by Diagnostic Ultrasound
Time frame: 10 (+/-3) days and any time there is clinically suspected venous thrombosis (as per standard of care)
Population: The study was prematurely terminated and the PI was blinded to study data, and therefore never had access to the data and does not have any information that might help us locate it. Additionally, AngioDynamics' IT team ran a thorough search for any data related to this study and no results were found.
Secondary
Incidence of Other Catheter-related Complications
Secondary objectives of this study are to investigate: * Incidence of other catheter-related complications, inclusive of catheter occlusion, catheter-related infection, technical failures, and premature catheter removals * Incidence of catheter occlusion (independently from other catheter-related complications)
Time frame: Up to 30 days post-insertion
Population: The study was prematurely terminated and the PI was blinded to study data, and therefore never had access to the data and does not have any information that might help us locate it. Additionally, AngioDynamics' IT team ran a thorough search for any data related to this study and no results were found.
Other Pre-specified
Medical Resource Utilization Data Analysis
Economic outcomes with respect to medical resource utilization requirements will be compared between the two PICC groups. Only data from US sites will be used for this analysis.
Time frame: Up to 30 days post-insertion