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

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ClinicalTrials.gov Identifier: NCT01921114
Recruitment Status : Terminated (Low enrollment)
First Posted : August 13, 2013
Last Update Posted : August 18, 2014
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.

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.

Condition or disease Intervention/treatment Phase
Patients Indicated for a PICC for Any Medical Condition Device: BioFlo™ Peripherally Inserted Central Catheter (PICC) Device: Bard® Dual-Lumen PowerPICC SOLO2® Not Applicable

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  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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®
Study Start Date : October 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Diazepam

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®



Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Incidence of other catheter-related complications [ Time Frame: 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 Outcome Measures:
  1. Medical Resource Utilization Data Analysis [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921114


Locations
United States, Florida
University of Miami Hospital
Miami, Florida, United States, 33136
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
United States, Kentucky
University of Louisville/Norton Hospital
Louisville, Kentucky, United States, 40202
Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Angiodynamics, Inc.
Investigators
Principal Investigator: David Hahn, MD NorthShore University HealthSystem

Responsible Party: Angiodynamics, Inc.
ClinicalTrials.gov Identifier: NCT01921114     History of Changes
Other Study ID Numbers: VA-BF400
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014