The PROOF Study: The PICC Related Obstruction Of Flow Study (PROOF)

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®

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.

Study Overview

• Status: Terminated
• Conditions: Patients Indicated for a PICC for Any Medical Condition
• Intervention / Treatment: Device: BioFlo™ Peripherally Inserted Central Catheter (PICC); Device: Bard® Dual-Lumen PowerPICC SOLO2®

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).

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital
• Switzerland
  • Lausanne, Switzerland, 1011
    • Centre Hospitalier Universitaire Vaudois (Chuv)
• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Hospital
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University Healthsystem
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville/Norton Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: BioFlo™ PICC; BioFlo™ Peripherally Inserted Central Catheter (PICC)	Device: BioFlo™ Peripherally Inserted Central Catheter (PICC)
ACTIVE_COMPARATOR: Bard® PowerPICC SOLO2®; Bard® Dual-Lumen PowerPICC SOLO2®	Device: Bard® Dual-Lumen PowerPICC SOLO2®

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Angiodynamics, Inc.
• Investigators: Principal Investigator: David Hahn, MD, NorthShore University Healthsystem

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: August 8, 2013
• First Submitted That Met QC Criteria: August 9, 2013
• First Posted (ESTIMATE): August 13, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: VA-BF400