Safety and Suitability of Supplementing Early MIP Surgery (MIPS) of ICH With Pioglitazone

Exclusion Criteria

• •1. Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, moyamoya disease, hemorrhagic conversion of an ischemic infarct, or bleeding into a known neoplastic lesion
• •2. NIHSS\< 5, bilateral fixed dilated pupils, extensor motor posturing, unstable mass or evolving intracranial compartment syndrome
• •3. Intraventricular extension of the hemorrhage estimated to involve \>50% of either of the lateral ventricles (External ventricular drain (EVD) to treat intracranial pressure (ICP) or hydrocephalus is allowed)
• •4. Primary thalamic ICH or infratentorial intraparenchymal hemorrhage including midbrain, pons or cerebellum
• •5. Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site
• •6. Severe kidney or liver disease (serum ALT \> 2.5 x ULN) with active coagulopathy
• •7. Patients requiring long-term anticoagulation that needs to be initiated \< 5 days from index ICH; patient must not require Coumadin (anticoagulation) during the first 30 days (reversal of anticoagulation is permitted for medically stable patients who can safely tolerate the short-term risk of reversal)
• •8. Use of anticoagulants that cannot be rapidly reversed, uncorrected coagulopathy or known clotting disorder
• •9. Platelet count \< 75,000
• •10. International Normalized Ratio (INR) \> 1.4 after correction or inability to sustain INR ≤ 1.4 using short- and long-active procoagulants (such as, but not limited to, NovoSeven, fresh frozen plasma, vitamin K, Kcentra or Feiba)
• •11. Untreatable elevated activated partial thromboplastin time (aPTT)
• •12. Patients with a mechanical heart valve (presence of bioprosthetic valve(s) is permitted)
• •13. Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or is post-menopausal
• •14. Participation in a concurrent interventional medical investigation or clinical trial
• •15. Known life-expectancy of less than 6 months, no reasonable expectation of recovery, Do-Not-Resuscitate (DNR), or comfort measures only prior to randomization
• •16. Inability or unwillingness of subject or legal guardian/representative to give written informed consent
• •17. Homelessness or history of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
• •18. intolerance or allergy to any TZD1
• •19. T2DM treated with insulin or an oral medication including Glyburide, unless the NICU physician deems it safe to replace the T2DM medication with pioglitazone1
• •20. heart failure (symptomatic or NYHA Class I-IV or newly diagnosed on admission TTE screening)
• •21. patients with abnormal (\>1x upper limit of normal) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin