The PROOF Study: The PICC Related Obstruction Of Flow Study

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Randomized Prospective Multicenter Evaluation to Investigate the Incidence of Catheter Related Venous Thrombosis in Patients Undergoing Intravenous Therapy With the BioFlo™ Peripherally Inserted Central Catheter (PICC) or Bard® Dual-Lumen PowerPICC SOLO2®

Conditions
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Patients Indicated for a PICC for Any Medical Condition

Intervention / Treatment
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* Device: BioFlo™ Peripherally Inserted Central Catheter (PICC)
* Device: Bard® Dual-Lumen PowerPICC SOLO2®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is indicated for a PICC based on institutional practices Is ≥ 18 years of age Is expected to require use of a PICC for a minimum of 10 days Has normal findings on initial ultrasonography (complete Ultrasound Checklist) Vein used for PICC placement must be a minimum of 5mm in diameter 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: Anticipates or has presence of dialysis grafts or other ipsilateral intraluminal devices, including pacemakers (with the exception of peripheral IV catheters) 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) Has central veno-occlusive disease Has history of previous catheter-related thrombosis 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) Is pregnant or lactating 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BioFlo™ PICC<br>BioFlo™ Peripherally Inserted Central Catheter (PICC) | Device: BioFlo™ Peripherally Inserted Central Catheter (PICC)<br> <br> |
| Active Comparator: Bard® PowerPICC SOLO2®<br>Bard® Dual-Lumen PowerPICC SOLO2® | Device: Bard® Dual-Lumen PowerPICC SOLO2®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Up to 30 days post-insertion |