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

Study Arms:

Group 1: 20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks

Group 2: Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device as part of the ENRICH trial (NCT02880878). These subjects will be enrolled at an ENRICH trial site independent of our Institution. Deidentified patient information from 20 subjects in this group, who will be matched to those in the ENRICH-PLUS group, will be provided to the principal investigator for comparison of outcomes.

Consent for study participation will be obtained from the patient or the LAR only after fulfilling all inclusion and exclusion criteria either before or after MIPS, which will be scheduled as a standard institutional procedure outside the realm of the study.

Study participants will be administered pioglitazone (15 mg tablet) either p.o. or enteral (via nasogastric tube). The first dose may be administered prior to surgery or within 3 hours of the end of surgery but must be administered within 24 hours of the index event or time last known normal (TLKN). Pioglitazone (15 mg tablet) administration will continue 3 times daily for 3 weeks, including after hospital discharge, if applicable.

Following completion of pioglitazone, subjects will be followed at days 30, 90, 120 and 180 post MIPS. In addition to AE monitoring during these follow up's, a utility-weighted mRS (uw-mRS) at 180 days will serve as the primary end point.