Ignite Creation Date:
2024-05-06 @ 6:13 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05582707
Status:
TERMINATED
Last Update Posted:
2024-06-27
First Post:
2022-10-03
Brief Title:
Safety and Suitability of Supplementing Early MIP Surgery MIPS of ICH With Pioglitazone
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Loss of Financial Sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENRICHPLUS
Brief 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
Detailed Description:
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 po 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 ups a utility-weighted mRS uw-mRS at 180 days will serve as the primary end point
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 po 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 ups a utility-weighted mRS uw-mRS at 180 days will serve as the primary end point
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None