- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01971359
Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study (MISPACE)
May 18, 2016 updated by: Andrew Tsung, OSF Healthcare System
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Patients will be recruited form the neurology and neurosurgery services at OSF Saint Francis Medical Center.
Potential subjects will be identified by the study team which will include all investigators and study coordinators.
For those patients who have had the Mi Space procedure, the study team will obtain the patients or patient's surrogate consent for clinical data of hospitalization and follow ups.
A secured, de-identified log will be kept of all patients screened, and reasons for exclusion will be documented.
Around 65% of unselected patients with ICH (not stratified by baseline predicted risk) have a documented 30 day composite outcome of death or dependency under medical management.
Reviews of other types of minimally-invasive ICH surgeries provides data that significantly improved outcomes (meta-analysis odds ratio 0.54(0.39,
0.76)).
An odds ratio of 0.54 shows a reduction in risk from 65% to about 50% (15% absolute reduction).
Assuming the new procedure is at least as effective than current conventional management, 50 patients provides 66% surety that a 95% 1-sided confidence interval will exclude the chance that the new procedure is worse than medical management.
Alternatively, a method of framing this, based on an exact one-sided binomial test of a one-sample proportion and an alpha level of 5%, is that a sample size of 50 patients provides approximately 66% surety/power that the new procedure is superior to medical management (i.e., lower than 65% suffering from death or poor functional outcomes).
The critical computed value for this particular test, to provide some initial evidence of superiority, are observing no more than 26 patients (out of 50) suffering from death or dependency under the surgical procedure.
Study Type
Observational
Enrollment (Actual)
2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Peoria, Illinois, United States, 61637
- OSF St. Francis Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients that present with an ICH at OSF St. Francis Medical Center
Description
Inclusion Criteria:
1. Inclusion Criteria:
- Consecutive patients aged at 18-80 presenting with an acute symptomatic supratertorial primary ICH diagnosed by CT
- Symptom onset to surgery <24 hours (target <8 hours)
- Glascow Coma Score > 9
- Hematoma Volume, between 10ml and 50ml.
- Minimal or no ventricular extension (corresponding to 50% or less of each ventricle)
- NIHSS of >4 or deterioration determined by a neurologist.
Exclusion Criteria:
- Suspected secondary ICH
- Infratentorial ICH
- Isolated IVH
- Uncorrected coagulopathy
- Significant premorbid disability (mRS >1)
- Hydrocephalus
- Contraindication to safe surgical procedure as per neurosurgeon (justification for exclusion on this basis will be recorded)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Retrospective
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
30-90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30-90 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30-90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew Tsung, M.D., OSF HealthCare System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
October 23, 2013
First Submitted That Met QC Criteria
October 23, 2013
First Posted (Estimate)
October 29, 2013
Study Record Updates
Last Update Posted (Estimate)
May 19, 2016
Last Update Submitted That Met QC Criteria
May 18, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSF-13-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intracerebral Hemorrhage
-
Wake Forest University Health SciencesActive, not recruitingStroke Hemorrhagic | Intracerebral Hemorrhage | Cerebral Edema | Intracerebral Hemorrhage, Hypertensive | Intracerebral Hemorrhage IntraparenchymalUnited States
-
Beijing Tiantan HospitalBeijing Friendship Hospital; RenJi Hospital; Qilu Hospital of Shandong University and other collaboratorsRecruitingSpontaneous Intracerebral HemorrhageChina
-
University Hospital, Basel, SwitzerlandSwiss Heart FoundationActive, not recruitingIntracerebral Hemorrhage (ICH)Switzerland
-
University of Erlangen-Nürnberg Medical SchoolCompleted
-
AegisCN LLCCompletedIntracerebral Hemorrhage (ICH)United States
-
Tongji HospitalUnknown
-
Huazhong University of Science and TechnologyUnknownHypertensive Intracerebral HemorrhageChina
-
Huazhong University of Science and TechnologyUnknownHypertensive Intracerebral HemorrhageChina
-
CellMed AG, a subsidiary of BTG plc.TerminatedIntracerebral Hemorrhage (ICH)Germany
-
Tang-Du HospitalRecruitingIntracerebral Hemorrhage;Circulating ExosomesChina