Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2025-12-26 @ 6:30 AM
Study NCT ID:
NCT01971359
Status:
COMPLETED
Last Update Posted:
2016-05-19
First Post:
2013-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006522', 'term': 'Hepatitis, Infectious Canine'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006524', 'term': 'Hepatitis, Viral, Animal'}, {'id': 'D006520', 'term': 'Hepatitis, Animal'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000257', 'term': 'Adenoviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004283', 'term': 'Dog Diseases'}, {'id': 'D000820', 'term': 'Animal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-18', 'studyFirstSubmitDate': '2013-10-23', 'studyFirstSubmitQcDate': '2013-10-23', 'lastUpdatePostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Financial outcomes', 'timeFrame': '30-90 days', 'description': 'We also will be looking at the financial aspect of current medical management and minimally invasive surgeries compared to the parafascicular technique.'}], 'primaryOutcomes': [{'measure': '30-90 day outcomes', 'timeFrame': '30-90 days', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Surgery success rates', 'timeFrame': '30-90 days', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stroke, Intracerebral Hemorrhage, ICH'], 'conditions': ['Intracerebral Hemorrhage']}, 'descriptionModule': {'briefSummary': '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.\n\n* H(0): there is no economic benefit to the system with early surgical intervention for ICH\n* 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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that present with an ICH at OSF St. Francis Medical Center', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Inclusion Criteria:\n\n* Consecutive patients aged at 18-80 presenting with an acute symptomatic supratertorial primary ICH diagnosed by CT\n* Symptom onset to surgery \\<24 hours (target \\<8 hours)\n* Glascow Coma Score \\> 9\n* Hematoma Volume, between 10ml and 50ml.\n* Minimal or no ventricular extension (corresponding to 50% or less of each ventricle)\n* NIHSS of \\>4 or deterioration determined by a neurologist.\n\nExclusion Criteria:\n\n* Suspected secondary ICH\n* Infratentorial ICH\n* Isolated IVH\n* Uncorrected coagulopathy\n* Significant premorbid disability (mRS \\>1)\n* Hydrocephalus\n* Contraindication to safe surgical procedure as per neurosurgeon (justification for exclusion on this basis will be recorded)'}, 'identificationModule': {'nctId': 'NCT01971359', 'acronym': 'MISPACE', 'briefTitle': 'Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'OSF Healthcare System'}, 'officialTitle': 'Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study', 'orgStudyIdInfo': {'id': 'OSF-13-004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective'}]}, 'contactsLocationsModule': {'locations': [{'zip': '61637', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'OSF St. Francis Medical Center', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}], 'overallOfficials': [{'name': 'Andrew Tsung, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OSF Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OSF Healthcare System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Andrew Tsung M.D.', 'investigatorFullName': 'Andrew Tsung', 'investigatorAffiliation': 'OSF Healthcare System'}}}}