Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-27 @ 4:29 AM
Study NCT ID:
NCT01448694
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2011-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Hemodynamic Monitoring During Blood Donation for Developing Models of Early Blood Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-01', 'studyFirstSubmitDate': '2011-10-05', 'studyFirstSubmitQcDate': '2011-10-06', 'lastUpdatePostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Algorithm', 'timeFrame': '24 months', 'description': 'Mathematical model of early blood loss'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemorrhage'], 'conditions': ['Hemorrhage']}, 'descriptionModule': {'briefSummary': 'This study is part of a Phase II STTR project to develop an algorithm called CipherSensor to apply feature extraction and machine learning techniques to non-invasive hemodynamic data to identify early signs of acute blood loss. The availability of this information may help to establish required interventions for treating trauma patients and battlefield casualties.\n\nStudy hypothesis: Hemodynamic changes measured non-invasively during the blood donation process can be modeled to provide early estimations of blood loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adults', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Approved by Children's Hospital Colorado Blood Donation Center for blood donation\n* Age 18 -89 years\n* Previously donated blood (lower likelihood of vasovagal response)\n\nExclusion Criteria:\n\n* Pregnant\n* Incarcerated\n* Limited access to or compromised monitoring sites for non-invasive sensors: finger, ear and forehead sensors, oral/nasal cannula, 3 ECG electrodes."}, 'identificationModule': {'nctId': 'NCT01448694', 'briefTitle': 'Non-invasive Hemodynamic Monitoring During Blood Donation for Developing Models of Early Blood Loss', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Non-invasive Hemodynamic Monitoring During Blood Donation for Developing Models of Early Blood Loss.', 'orgStudyIdInfo': {'id': '10-1421'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Blood donors', 'description': 'Healthy volunteers who are donating a pint of whole blood', 'interventionNames': ['Other: No treatment']}], 'interventions': [{'name': 'No treatment', 'type': 'OTHER', 'description': 'No treatment, only collecting observational data.', 'armGroupLabels': ['Blood donors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Steve Moulton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Colorado"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}