Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-01 @ 11:29 PM
Study NCT ID:
NCT00961532
Status:
COMPLETED
Last Update Posted:
2014-08-28
First Post:
2009-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003894', 'term': 'Deamino Arginine Vasopressin'}], 'ancestors': [{'id': 'D001127', 'term': 'Arginine Vasopressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a-naidech@northwestern.edu', 'phone': '312-503-3335', 'title': 'Andrew M Naidech', 'organization': 'Northwestern Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'DDAVP', 'description': 'DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes\n\nDDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DDAVP', 'description': 'DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes\n\nDDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '24.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000'], 'groupDescription': 'We tested the hypothesis that there would be a change from baseline to 60 minutes after the start of the desmopressin (DDAVP) infusion.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '60 minutes after treatment start', 'description': 'The Platelet Function Analyzer (PFA) is a commercially available point-of-care assay that measures the time to closure of an aperature. Longer time to closure indicates less platelet activity. EPI denotes epinephrine (as opposed to adenosine diphosphate) as the stimulant to platelet aggregation. In our laboratory, a time to closure of at least 172 seconds in consistent with an aspirin effect.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events : New Fever >=100.4F, Respiratory Distress or Pulmonary Edema on Chest Radiography, Rash, Hypotension (Systolic BP < 100 mm Hg or New Vasopressor Use or Increase in Vasopressor Dose by >25%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DDAVP', 'description': 'DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes\n\nDDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 6 hours of study treatment', 'description': 'We prospectively defined acute adverse events as: new fever \\>=100.4F, respiratory distress or pulmonary edema on chest radiography, rash, hypotension (systolic BP \\< 100 mm Hg or new vasopressor use or increase in vasopressor dose by \\>25%). The two patients reported were the only two that sustained any of the prospectively defined adverse events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DDAVP', 'description': 'DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes\n\nDDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'DDAVP', 'description': 'DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes\n\nDDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'spread': '14.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-11', 'studyFirstSubmitDate': '2009-08-17', 'resultsFirstSubmitDate': '2014-07-16', 'studyFirstSubmitQcDate': '2009-08-18', 'lastUpdatePostDateStruct': {'date': '2014-08-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-11', 'studyFirstPostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Platelet Activity, Measured in Seconds on PFA-EPI Assay, From Pre to Post-treatment', 'timeFrame': '60 minutes after treatment start', 'description': 'The Platelet Function Analyzer (PFA) is a commercially available point-of-care assay that measures the time to closure of an aperature. Longer time to closure indicates less platelet activity. EPI denotes epinephrine (as opposed to adenosine diphosphate) as the stimulant to platelet aggregation. In our laboratory, a time to closure of at least 172 seconds in consistent with an aspirin effect.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events : New Fever >=100.4F, Respiratory Distress or Pulmonary Edema on Chest Radiography, Rash, Hypotension (Systolic BP < 100 mm Hg or New Vasopressor Use or Increase in Vasopressor Dose by >25%)', 'timeFrame': 'within 6 hours of study treatment', 'description': 'We prospectively defined acute adverse events as: new fever \\>=100.4F, respiratory distress or pulmonary edema on chest radiography, rash, hypotension (systolic BP \\< 100 mm Hg or new vasopressor use or increase in vasopressor dose by \\>25%). The two patients reported were the only two that sustained any of the prospectively defined adverse events.'}]}, 'conditionsModule': {'keywords': ['intracerebral hemorrhage', 'platelets'], 'conditions': ['Intracerebral Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '25005444', 'type': 'RESULT', 'citation': 'Naidech AM, Maas MB, Levasseur-Franklin KE, Liotta EM, Guth JC, Berman M, Rosenow JM, Lindholm PF, Bendok BR, Prabhakaran S, Bernstein RA, Kwaan HC. Desmopressin improves platelet activity in acute intracerebral hemorrhage. Stroke. 2014 Aug;45(8):2451-3. doi: 10.1161/STROKEAHA.114.006061. Epub 2014 Jul 8.'}]}, 'descriptionModule': {'briefSummary': 'The investigators intend to show that DDAVP improves platelet activity from baseline to 60 minutes after treatment start.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spontaneous intracerebral hemorrhage as documented by head CT scan\n* Documented regular aspirin use or VerifyNow-ASA result of ≤ 550 aspirin reaction units (ARU), indicating anti-platelet medication\n\nExclusion Criteria:\n\n* International normalized ratio (INR) of ≥ 1.7 from coagulopathy or warfarin use\n* History of von Willebrand disease\n* Pregnancy\n* Known hypersensitivity to DDAVP or desmopressin\n* Active cardiovascular disease or unstable angina\n* Hyponatremia or history of hyponatremia\n* Current or historical deep venous thrombosis or pulmonary embolism'}, 'identificationModule': {'nctId': 'NCT00961532', 'acronym': 'IMPACT', 'briefTitle': 'Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept', 'orgStudyIdInfo': {'id': 'STU8168'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DDAVP', 'description': 'DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes', 'interventionNames': ['Drug: DDAVP injection (desmopressin acetate)']}], 'interventions': [{'name': 'DDAVP injection (desmopressin acetate)', 'type': 'DRUG', 'description': '0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes', 'armGroupLabels': ['DDAVP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Andrew M Naidech, MD MSPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwestern Memorial Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Andrew Naidech', 'investigatorAffiliation': 'Northwestern University'}}}}