Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study (MISPACE)
|ClinicalTrials.gov Identifier: NCT01971359|
Recruitment Status : Completed
First Posted : October 29, 2013
Last Update Posted : May 19, 2016
This study is determining the clinical outcomes, based on neurological testing, for the parafascicular minimally invasive clot evacuation technique. We will collect data from the time of surgery up until 90 days post procedure. We will also be looking at financial data as well.
- H(0): there is no economic benefit to the system with early surgical intervention for ICH
- Alternative Hypothesis:H(1) Assuming clinical equipoise, i.e., no benefit in clinical outcome with early surgical intervention (null hypotheses) H(0) is correct), the ability to accelerate the patients care from the entry point to the exit point will result in a significant economic advantage to the system through cost reduction.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||2 participants|
|Official Title:||Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study|
|Study Start Date :||September 2013|
|Primary Completion Date :||September 2014|
|Study Completion Date :||October 2014|
- 30-90 day outcomes [ Time Frame: 30-90 days ]The primary objective is to compare the 30 day and 90 day clinical outcomes of patients who will undergo parafascicular ICH-evacuation procedure compared to historical outcomes (surgical and non-surgical).
- Surgery success rates [ Time Frame: 30-90 days ]Another objective will be to describe and quantify peri-operative complications following the parafascicular ICH evacuation. We will assess the success rates of; atraumatic access to the hematoma, effective removal of fibrotic clot by measuring residual hematoma, the ability to achieve hemostasis intra-operatively, and to compare postoperative re-bleeding rates against residual clot volume.
- Financial outcomes [ Time Frame: 30-90 days ]We also will be looking at the financial aspect of current medical management and minimally invasive surgeries compared to the parafascicular technique.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971359
|United States, Illinois|
|OSF St. Francis Medical Center|
|Peoria, Illinois, United States, 61637|
|Principal Investigator:||Andrew Tsung, M.D.||OSF St. Francis Medical Center|