Patients Indicated for a PICC for Any Medical Condition | The PROOF Study: The PICC Related Obstruction Of Flow Study
Patients Indicated for a PICC for Any Medical Condition research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Patients Indicated for a PICC for Any Medical Condition
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:BioFlo™ Peripherally Inserted Central Catheter (PICC)
Device:Bard® Dual-Lumen PowerPICC SOLO2®
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
BioFlo™ PICCBioFlo™ Peripherally Inserted Central Catheter (PICC)
Bard® PowerPICC SOLO2®Bard® Dual-Lumen PowerPICC SOLO2®
Start Date: October 2013
Completed Date: August 2014
Primary Outcome: Incidence of catheter-related venous thrombosis as confirmed by diagnostic ultrasound
Secondary Outcome: Incidence of other catheter-related complications
Study sponsors, principal investigator, and references
Principal Investigator: David Hahn, MD
Lead Sponsor: Angiodynamics, Inc.