Intracerebral HemorrhageMISPACENCT01971359
Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study
An observational study of Intracerebral Hemorrhage, run by OSF Healthcare System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracerebral Hemorrhage
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients that present with an ICH at OSF St. Francis Medical Center
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
OSF St. Francis Medical Center
Peoria, Illinois, 61637
About this study
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.
Read the 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.
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Stroke, Intracerebral Hemorrhage, ICH
- Medical subject headings
- Cerebral Hemorrhage, Stroke, Hepatitis, Infectious Canine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-90 day outcomes
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).
Measured: 30-90 days
Secondary outcomes (1)
Surgery success rates
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.
Measured: 30-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSF Healthcare System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Tsung, OSF Healthcare System
- Investigators
- Andrew Tsung, M.D., Principal investigator, OSF Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971359
- Sponsor's protocol ID
- OSF-13-004
- Acronym
- MISPACE
- Status last verified
- May 2016
- First submitted
- 23 Oct 2013
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study
- ClinicalTrials.gov ID
- NCT01971359
- Acronym / sponsor ID
- MISPACE / OSF-13-004
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Stroke, Intracerebral Hemorrhage, ICH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- OSF Healthcare SystemUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that present with an ICH at OSF St. Francis Medical Center
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- Suspected secondary ICH
- Infratentorial ICH
- Isolated IVH
- Uncorrected coagulopathy
- Significant premorbid disability (mRS >1)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Surgery success rates
Time frame: 30-90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Tsung, M.D. principal investigator
OSF Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage, run by OSF Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-90 day outcomes (time frame: 30-90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.