Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT04470505
Status:
COMPLETED
Last Update Posted:
2025-10-17
First Post:
2020-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimizing Platelet Isolation (The Cell Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2020-07-02', 'studyFirstSubmitQcDate': '2020-07-13', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet activation from isolated platelets', 'timeFrame': 'day 1', 'description': 'Whole blood will be collected following an overnight fast, and platelets isolated using standard procedures. Platelet activation markers (e.g., CD62P ) will be measured using flow cytometric analysis.'}], 'secondaryOutcomes': [{'measure': 'Platelet activation measured in whole blood', 'timeFrame': 'day 1', 'description': 'Whole blood will be collected following an overnight fast. Platelet activation will be measured in whole blood by the expression CD62P'}, {'measure': 'Platelet reactivity measured in whole blood', 'timeFrame': 'day 1', 'description': 'Whole blood will be collected following an overnight fast. Platelet reactivity will be measured in whole blood with adenosine diphosphate (ADP).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The research study is about blood cells (platelets) and their power houses (mitochondria). The investigators want to learn about their behavior in order to ensure that our laboratory procedures are generating optimal results.', 'detailedDescription': 'The objectives of this study are to assess platelet activation following standard laboratory procedures used in the process of measuring platelet mitochondrial function, and to determine the optimal amount of digitonin needed to permeabilize platelet cell membrane.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '25-35 years old', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 25-35\n* All races\n* All ethnicity\n* 18.5 - 30 BMI\n\nExclusion Criteria:\n\n* smoking\n* Aspirin intake\n* Recreational drug use\n* Alcohol intake more than 3 times per week\n* Self-reported possibility of current pregnancy\n* Known diagnosis of:\n* Pre-diabetes\n* Diabetes\n* High cholesterol\n* High triglycerides\n* Hypertension\n* Anemia\n* Autism spectrum disorder\n* Attention deficit hyperactivity disorder (ADHD)\n* Attention deficit disorder (ADD)\n* Severe asthma\n* Refusal to stop taking nutritional supplements\n* Any other pre-existing medical condition that requires daily medication as determined by the investigators to affect outcome of interest'}, 'identificationModule': {'nctId': 'NCT04470505', 'briefTitle': 'Optimizing Platelet Isolation (The Cell Study)', 'organization': {'class': 'OTHER', 'fullName': "Arkansas Children's Hospital Research Institute"}, 'officialTitle': 'Optimizing Platelet Isolation for Measures of Human Platelet Mitochondrial Respiration (The Cell Study)', 'orgStudyIdInfo': {'id': '260236'}}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Nutrition Center", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}