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TERMINATED
NCT05582707
PHASE2

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

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

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.

Official title: A Non-Randomized Controlled Trial to Examine the Safety and Suitability of Supplementing Early Minimally Invasive Parafascicular Surgery (MIPS) for Clot Evacuation of Basal Ganglia Intracerebral Hemorrhage (ICH) With Pioglitazone

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1

Start Date

2023-05-08

Completion Date

2025-12-25

Last Updated

2026-04-28

Healthy Volunteers

No

Interventions

DRUG

Pioglitazone 15mg

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.

Locations (1)

University of Maryland, Baltimore

Baltimore, Maryland, United States