This is an exploratory single-center prospective study of 20 subjects with primary basal ganglia ICH who will receive early MIPS in combination with perioperative pioglitazone treatment. Outcomes will be compared to matched subjects with basal ganglia ICH who undergo MIPS alone as part of the ENRICH trial. This study will take approximately two years to complete.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
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.
University of Maryland, Baltimore
Baltimore, Maryland, United States
Functional Improvement - modified Rankin Scale (mRS)
Functional Improvement as determined by utility-weighted modified Rankin Scale (mRS) at 180 days. This is a scale from 0 to 6, where 0 is the best score (no symptoms) and 6 is the worst score.
Time frame: 180 Days
Efficacy as demonstrated by hematoma clearance
Determination whether there is non-inferiority or a trend toward more rapid hematoma clearance and perihematomal edema in Group 1 compared to the control arm (Group 2) as measured by serial CT scans during hospitalization residual clot on CT, perihematomal edema on CT
Time frame: 7 Days
Safety: Number of Participants with 30-day mortality
30-day mortality (30 days from intervention)
Time frame: 30 days
Safety: hemorrhage volume
increase in hemorrhage volume between index CT and 24-hour follow-up CT
Time frame: 24 Hours
Safety: Number of Participants with bacterial brain infection
30-day bacterial brain infection (30 days from intervention)
Time frame: 30 Days
Safety: Number of Participants with hypoglycemia
occurrences of Moderate hypoglycemia (\<70 mg/dL) or Severe hypoglycemia (\<50 mg/dL) requiring rescue therapy
Time frame: 30, 90, 120, and 180 days
Safety: Number of Participants with Drug Toxicity
Time frame: 30, 90, 120, and 180 days
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Economic
Economic differential as determined by quantification of the cost per quality-adjusted life-years (QALY). QALY uses a scale of 0.00 (dead) to 1.00 (perfect health) for each health status. It is the product of duration of life and a measurement of quality of life.
Time frame: 30, 90, 120, and 180 days