Safety and Suitability of Supplementing Early MIP Surgery (MIPS) of ICH With Pioglitazone (NCT05582707) | Clinical Trial Compass
TerminatedPhase 2
Safety and Suitability of Supplementing Early MIP Surgery (MIPS) of ICH With Pioglitazone
Stopped: Loss of Financial Sponsor
United States1 participantsStarted 2023-05-08
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age 18-80 years
✓. CT scan demonstrating an acute, spontaneous, primary basal ganglia ICH
✓. ICH volume between 30 - 80 mL as calculated by the ABC/2 method
✓. 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
✓. Glasgow Coma Score (GCS) 5 - 14
✓. Historical Modified Rankin Score 0 or 1
✓. Consent by patient or LAR to MIS evacuation of the ICH based on best medical practice1
✓. Time to pioglitazone treatment ≤ 24 hours from symptom onset or TLKN1
Exclusion criteria
✕. Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, moyamoya disease, hemorrhagic conversion of an ischemic infarct, or bleeding into a known neoplastic lesion
✕. NIHSS\< 5, bilateral fixed dilated pupils, extensor motor posturing, unstable mass or evolving intracranial compartment syndrome
✕. 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)
✕. Primary thalamic ICH or infratentorial intraparenchymal hemorrhage including midbrain, pons or cerebellum
✕. Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site
✕. Severe kidney or liver disease (serum ALT \> 2.5 x ULN) with active coagulopathy
✕. 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)
✕. Use of anticoagulants that cannot be rapidly reversed, uncorrected coagulopathy or known clotting disorder