The PROOF Study: The PICC Related Obstruction Of Flow Study
Stopped early · Not applicable
Conditions studied: Patients Indicated for a PICC for Any Medical Condition
In brief
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.
Key facts
- Study ID
- NCT01921114
- Run by
- Angiodynamics, Inc.
- People needed
- 57
- Starts
- 2013-10-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2019-05-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University of Miami Hospital — Miami, Florida, United States
- NorthShore University HealthSystem — Evanston, Illinois, United States
- University of Louisville/Norton Hospital — Louisville, Kentucky, United States
- Ottawa Hospital — Ottawa, Ontario, Canada
- Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Switzerland
Full record on ClinicalTrials.gov
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