The PROOF Study: The PICC Related Obstruction Of Flow Study

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