A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations

Exclusion Criteria

• •1. Diagnosis of documented infection, thromboembolic disease, an additional etiology for acute lung injury/adult respiratory distress syndrome, congestive heart failure.
• •2. Presence of active hepatitis B infection.
• •3. Coagulopathy defined as an INR \> 1.8, PTT \> 2 x control, and platelet count \< 50K.
• •4. Hyperosmolar state or diabetic ketoacidosis to suggest uncontrolled diabetes mellitus or uncontrolled hypertension.
• •5. Hemodynamic instability.
• •6. History of reaction to blood products, murine-derived products, or prior exposures to human-murine chimeric antibodies,
• •7. History of malignancy.
• •8. Unwillingness to accept a blood transfusion.
• •9. Unwillingness to agree to full supportive medical care (e.g., intubation) for up to 2 weeks after enrollment.
• •10. Inability or unwillingness to complete post-treatment surveillance for 60 days.
• •11. Diagnosis of major comorbidities expected to interfere with subjects study participation for 28 days.
• •12. Treatment for \>5 days within the preceding month with \>20 mg prednisone (or equivalent dose corticosteroid) or any treatment during the preceding month with a potent cellular immunosuppressant (e.g., cyclophosphamide, methotrexate, mycophenolate, azathiaprine, calcineurin inhibitors, etc.) unless the patient has a BAL negative for opportunistic pathogens (e.g, Pneumocystis, viruses, intracellular organisms, mycobacteria, etc.).
• •13. Current treatment with an angiotensin converting enzyme inhibitor that cannot be discontinued and/or substituted with another antihypertensive agent (to minimize potential hemodynamic complications during PEX).