Status:
TERMINATED
The PROOF Study: The PICC Related Obstruction Of Flow Study
Lead Sponsor:
Angiodynamics, Inc.
Conditions:
Patients Indicated for a PICC for Any Medical Condition
Eligibility:
All Genders
18+ years
Phase:
NA
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 commer...
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01921114
Start Date
October 1 2013
End Date
August 1 2014
Last Update
May 17 2019
Active Locations (5)
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1
University of Miami Hospital
Miami, Florida, United States, 33136
2
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
3
University of Louisville/Norton Hospital
Louisville, Kentucky, United States, 40202
4
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6