Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT01414894
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2010-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-18', 'studyFirstSubmitDate': '2010-04-05', 'studyFirstSubmitQcDate': '2011-08-10', 'lastUpdatePostDateStruct': {'date': '2013-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Our primary endpoint is to determine the feasibility of the pilot study within the ICU setting and collect preliminary estimates for sample size calculations.', 'timeFrame': '6 months', 'description': '1\\. Estimation of the eligible population once specific study inclusion \\& exclusion criteria are applied 2. Estimation of enrollment projections, retention, attrition \\& losses to follow up; 3. Assessment of compliance with protocol instructions; 4. Evaluation of protocol violations; 5. Achievement of pre-determined hemodynamic goals in each study group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Subarachnoid Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '25549192', 'type': 'DERIVED', 'citation': 'Togashi K, Joffe AM, Sekhar L, Kim L, Lam A, Yanez D, Broeckel-Elrod JA, Moore A, Deem S, Khandelwal N, Souter MJ, Treggiari MM. Randomized pilot trial of intensive management of blood pressure or volume expansion in subarachnoid hemorrhage (IMPROVES). Neurosurgery. 2015 Feb;76(2):125-34; discussion 134-5; quiz 135. doi: 10.1227/NEU.0000000000000592.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of our study is to determine how well Triple-H works and how safe it is. The investigators are hoping to determine the effects of starting the therapy early and to explore if hypervolemia and/or hypertension are beneficial, and what the optimal target ranges are.', 'detailedDescription': 'Efficacy of Triple-H therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age more than or equal to 18 years\n2. Aneurysmal SAH of any clinical grade\n3. Head computed tomography demonstrating SAH\n4. Cerebral angiography revealing the presence of cerebral aneurysm(s) in a location that explains the SAH\n5. Treatment of aneurysm with clipping or coiling must be carried out prior to randomization and within 72 hours of bleeding\n6. Signed consent by study participant or applicable legal representative within 72 hours after SAH\n\nExclusion Criteria:\n\n1. History of traumatic SAH\n2. Non-aneurysmal SAH as indicated by no demonstrable aneurysm by cerebral angiography\n3. Presence of an unsecured intracranial aneurysm(s) at risk of rupture that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data\n4. Delayed referral with clipping/coiling greater than 72 hours after the initial bleeding\n5. Time of symptom onset cannot be reliably determined\n6. Intracranial hypertension (ICP \\>25 mm Hg) at the time of screening\n7. History within the past six months and/or physical findings on admission of decompensated congestive heart failure (NYHA functional class III or IV, or objective class C or D)\n8. Acute, evolving or recent myocardial infarction\n9. Cardiac arrhythmia or second and third degree atrio-ventricular block causing hemodynamic instability\n10. Chronic renal failure requiring dialysis\n11. Suspected or confirmed pregnancy\n12. Non English speaking\n13. A condition that would preclude the performance of the neurobehavioral test battery due to a prior diagnosis of Alzheimer's disease, stroke, degenerative condition, cerebral tumor, or mental retardation\n14. Severe terminal disease with life expectancy less than 6 months\n15. Refusal of consent"}, 'identificationModule': {'nctId': 'NCT01414894', 'acronym': 'IMPROVES', 'briefTitle': 'Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': '37222-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Normal Fluids & Normal Blood Pressure', 'description': 'Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure).', 'interventionNames': ['Other: Fluid manipulation', 'Other: Blood Pressure Manipulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Increased Fluids & Normal Blood Pressure', 'description': 'Patients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure)', 'interventionNames': ['Other: Fluid manipulation', 'Other: Blood Pressure Manipulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal Fluids & Higher Blood Pressure', 'description': 'Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure).', 'interventionNames': ['Other: Fluid manipulation', 'Other: Blood Pressure Manipulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Increased Fluids & Higher Blood Pressure', 'description': 'Patients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure).', 'interventionNames': ['Other: Fluid manipulation', 'Other: Blood Pressure Manipulation']}], 'interventions': [{'name': 'Fluid manipulation', 'type': 'OTHER', 'otherNames': ['Hypervolemia', 'Normovolemia'], 'description': 'Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.', 'armGroupLabels': ['Increased Fluids & Higher Blood Pressure', 'Increased Fluids & Normal Blood Pressure', 'Normal Fluids & Higher Blood Pressure', 'Normal Fluids & Normal Blood Pressure']}, {'name': 'Blood Pressure Manipulation', 'type': 'OTHER', 'otherNames': ['Conventional Blood Pressure', 'Augmented Blood Pressure'], 'description': 'Patients are treated with maintenance of blood pressure in a normal range (Conventional Blood Pressure) or increased the blood pressure (Augmented Blood Pressure) for 10 days.', 'armGroupLabels': ['Increased Fluids & Higher Blood Pressure', 'Increased Fluids & Normal Blood Pressure', 'Normal Fluids & Higher Blood Pressure', 'Normal Fluids & Normal Blood Pressure']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Miriam Treggiari, MD, PhH, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Miriam Treggiari', 'investigatorAffiliation': 'University of Washington'}}}}