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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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