Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-04 @ 4:55 PM
Study NCT ID:
NCT02411266
Status:
COMPLETED
Last Update Posted:
2021-09-13
First Post:
2015-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preconditioning With Limb Ischemia for Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-02', 'studyFirstSubmitDate': '2015-03-30', 'studyFirstSubmitQcDate': '2015-04-07', 'lastUpdatePostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical Outcome - number of patients with a good modified Rankin Scale, defined as less than 2', 'timeFrame': '90 days', 'description': 'The number of patients with a good modified Rankin Scale, defined as less than 2, in the control and intervention group.'}], 'primaryOutcomes': [{'measure': 'Safety Outcomes 1 - number of patients who develop deep vein thrombosis and thromboembolism', 'timeFrame': '90 days', 'description': 'The number of patients who develop deep vein thrombosis and thromboembolism in the treatment and control group.'}, {'measure': 'Safety Outcome 2 - number of patients who develop neurovascular injury', 'timeFrame': '90 days', 'description': 'The number of patients who develop neurovascular injury in the treatment and control group.'}, {'measure': 'Safety Outcome 3 - number of patients who cannot tolerate the intervention due to discomfort', 'timeFrame': '90 days', 'description': 'The number of patients who cannot tolerate the intervention due to discomfort.'}, {'measure': 'Safety Outcome 4 - number of patients with cardiovascular events', 'timeFrame': '90 days', 'description': 'The number of patients with cardiovascular events \\[defined as hypotension, myocardial ischemia\\]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Preconditioning']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about protecting the brain from dangerous low blood flow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with aneurysmal subarachnoid hemorrhage whose initial angiogram show an aneurysm and patients with clipped aneurysm will be eligible for enrollment.\n* Patients will be enrolled within 96 hours of bleeding onset, if informed consent is obtained from the participant or health care proxy, as appropriate.\n\nExclusion Criteria:\n\n* Hunt Hess Scale \\> 4\n* Inability to undergo limb preconditioning due to local wound or tissue breakdown, history of peripheral extremity vascular disease or patient discomfort.\n* Inability to obtain informed consent from the patient or a health care proxy.\n* Ankle-brachial index \\< 0.7\n* Inability to start limb preconditioning within 4 days of bleeding.\n* Inability to precondition a leg that is not-plegic (that is preserved anti- gravity strength) and has not been accessed for catheter angiography\n* Age\\<18 years\n* Pregnant women\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT02411266', 'acronym': 'PreLIMBS', 'briefTitle': 'Preconditioning With Limb Ischemia for Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Remote Ischemic Preconditioning to Ameliorate Delayed Ischemic Neurological Deficit After Aneurysmal Subarachnoid Hemorrhage: a Safety and Feasibility Study', 'orgStudyIdInfo': {'id': '2008 0406 II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'Subjects in this group will undergo sham preconditioning. A blood pressure cuff will be placed around the leg and inflated just lightly to a pressure of 30mmHg, not enough to affect arterial circulation. This will be maintained for 10min followed by 5min of deflation. This will constitute one conditioning cycle. There will be 3 sham conditioning cycles per treatment session.', 'interventionNames': ['Other: ischemic conditioning group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'treatment group', 'description': "Study personnel will place a blood pressure cuff around the subject's leg and use it to interrupt the circulation to the leg for 10 minutes followed by release of the blood pressure for 5 minutes. This will be repeated for a total of 3 times every 24 to 48 hours up to 14 days. The cuff will be inflated for 10 minutes and then deflated for 5 minutes. There will be 3 cycles of this. The cuff will be inflated to 200mmHg to induce ischemia, confirmed by palpation of pedal pulses.", 'interventionNames': ['Other: ischemic conditioning group']}], 'interventions': [{'name': 'ischemic conditioning group', 'type': 'OTHER', 'otherNames': ['limb preconditioning'], 'description': 'application of a blood pressure cuff around a leg and inflating the cuff to 200mmHg to induce limb ischemia for 10min followed by 5min reperfusion. this will be done for 3 cycles every 24-48hours during the first 14 days after subarachnoid hemorrhage', 'armGroupLabels': ['control', 'treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Sebastian Koch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Clinical Neurology', 'investigatorFullName': 'Sebastian Koch', 'investigatorAffiliation': 'University of Miami'}}}}