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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01921114
Recruitment Status : Terminated (Low enrollment)
First Posted : August 13, 2013
Results First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.

Tracking Information
First Submitted Date  ICMJE August 8, 2013
First Posted Date  ICMJE August 13, 2013
Results First Submitted Date  ICMJE May 16, 2019
Results First Posted Date  ICMJE May 17, 2019
Last Update Posted Date May 17, 2019
Study Start Date  ICMJE October 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2013)
Incidence of Catheter-related Venous Thrombosis as Confirmed by Diagnostic Ultrasound [ Time Frame: 7-10 days, and any time there is clinically suspected venous thrombosis ]
Change History Complete list of historical versions of study NCT01921114 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2013)
Incidence of Other Catheter-related Complications [ Time Frame: 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)
Current Other Pre-specified Outcome Measures
 (submitted: April 29, 2014)
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The PROOF Study: The PICC Related Obstruction Of Flow Study
Official Title  ICMJE 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®
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Patients Indicated for a PICC for Any Medical Condition
Intervention  ICMJE
  • Device: BioFlo™ Peripherally Inserted Central Catheter (PICC)
  • Device: Bard® Dual-Lumen PowerPICC SOLO2®
Study Arms  ICMJE
  • Active Comparator: BioFlo™ PICC
    BioFlo™ Peripherally Inserted Central Catheter (PICC)
    Intervention: Device: BioFlo™ Peripherally Inserted Central Catheter (PICC)
  • Active Comparator: Bard® PowerPICC SOLO2®
    Bard® Dual-Lumen PowerPICC SOLO2®
    Intervention: Device: Bard® Dual-Lumen PowerPICC SOLO2®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 15, 2014)
57
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2013)
416
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01921114
Other Study ID Numbers  ICMJE VA-BF400
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angiodynamics, Inc.
Study Sponsor  ICMJE Angiodynamics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Hahn, MD NorthShore University HealthSystem
PRS Account Angiodynamics, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP