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

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland, Baltimore
• Collaborator: Nico Corporation
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

1. Age 18-80 years

2. CT scan demonstrating an acute, spontaneous, primary basal ganglia ICH

3. ICH volume between 30 - 80 mL as calculated by the ABC/2 method

4. Study intervention can reasonably be initiated within 24 hours after the onset of stroke symptoms. In situations with unclear time of onset, then the onset will be considered the time that the subject was last known to be well

5. Glasgow Coma Score (GCS) 5 - 14

6. Historical Modified Rankin Score 0 or 1

7. Consent by patient or LAR to MIS evacuation of the ICH based on best medical practice1

8. Time to pioglitazone treatment ≤ 24 hours from symptom onset or TLKN1

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