Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-31 @ 9:17 AM
Study NCT ID:
NCT00450151
Status:
COMPLETED
Last Update Posted:
2012-03-01
First Post:
2007-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet Activation Markers in Pediatric Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D003966', 'term': 'Camurati-Engelmann Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'For all patients, after obtaining written consent, 3.15ml of blood will be collected in CTAD tubes, from arterial line pre cardiopulmonary bypass and post cardiopulmonary bypass. Blood sample will be cooled in ice bath, centrifuged at 2500 rpm for 30 minutes, and supernatant plasma sample will be collected. This plasma will be stored at -20 degrees celcius or below. Enzyme-linked immunosorbent assay (ELISA) will be performed using the plasma to make quantitative assessment of platelet factor 4 and transforming growth factor beta.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-29', 'studyFirstSubmitDate': '2007-03-20', 'studyFirstSubmitQcDate': '2007-03-20', 'lastUpdatePostDateStruct': {'date': '2012-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pediatric', 'Cardiopulmonary bypass Surgery', 'Cardiac Surgery', 'Platelet', 'Platelet Activation Markers', 'Platelet Factor4', 'Transforming Growth Factor Beta'], 'conditions': ['Coronary Disease']}, 'referencesModule': {'references': [{'pmid': '11711459', 'type': 'BACKGROUND', 'citation': 'Garlichs CD, Eskafi S, Raaz D, Schmidt A, Ludwig J, Herrmann M, Klinghammer L, Daniel WG, Schmeisser A. Patients with acute coronary syndromes express enhanced CD40 ligand/CD154 on platelets. Heart. 2001 Dec;86(6):649-55. doi: 10.1136/heart.86.6.649.'}, {'pmid': '9972737', 'type': 'BACKGROUND', 'citation': 'Ichinose F, Uezono S, Muto R, Uchida H, Hatori F, Terui K, Niimi Y, Goto T, Nakata Y, Morita S. Platelet hyporeactivity in young infants during cardiopulmonary bypass. Anesth Analg. 1999 Feb;88(2):258-62. doi: 10.1097/00000539-199902000-00006.'}, {'pmid': '1716077', 'type': 'BACKGROUND', 'citation': 'Rinder CS, Bohnert J, Rinder HM, Mitchell J, Ault K, Hillman R. Platelet activation and aggregation during cardiopulmonary bypass. Anesthesiology. 1991 Sep;75(3):388-93. doi: 10.1097/00000542-199109000-00002.'}]}, 'descriptionModule': {'briefSummary': 'In this study the focus will be on correlating the levels of platelet activation markers (proteins that are released when blood cells are activated)to the duration of cardiopulmonary bypass, temperature during cardiopulmonary bypass and the weight of the patient.', 'detailedDescription': 'This research is being done because we would like to learn more about platelet dysfunction in children undergoing cardiopulmonary bypass.\n\nIt has been an established fact that cardiopulmonary bypass causes dysfunction in platelets. Activation of platelets during cardiopulmonary bypass is implicated as being a major factor in causing platelet dysfunction.\n\nFor all participants, approximately 3.15 ml of blood will be collected in special tubes called CTAD tubes, before and after cardiopulmonary bypass (6.30ml in total). This amount of blood draw is well within the guidelines of NIH (National Institute of Health).\n\nEnzyme-linked immunosorbent assay (ELISA) will be performed using this plasma to make quantitative assessment of Platelet factor 4 and Transforming growth factor beta.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The targeted population will be pediatric patients with congenital heart defects who will be needing cardiopulmonary bypass (CPB) while undergoing cardiac surgery. The age range will be newborn to 7 years of age.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled to have surgery involving cardiopulmonary bypass for congenital cardiac abnormalities.\n* Age: Newborn to 7 years\n* Gender: male and female\n\nExclusion Criteria:\n\n* Emergency surgery\n* Weight less than 3 kg\n* Age greater than 7 years\n* Patients with low platelet counts (\\<100,000)\n* Patients on medications that are known to interfere with platelet function such as prostacyclins, non-steroidal anti-inflammatory drugs, plavix.\n\nPatients whose parents not willing to give consent'}, 'identificationModule': {'nctId': 'NCT00450151', 'briefTitle': 'Platelet Activation Markers in Pediatric Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Effect of Cardiopulmonary Bypass on Platelet Activation Markers Such as Platelet Factor 4 and Transforming Growth Factor B, in Pediatric Cardiac Surgery', 'orgStudyIdInfo': {'id': '0612008895'}}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NewYork-Presbyterian Hospital-Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Aarti Sharma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College-New York Presbyterian Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesiology', 'investigatorFullName': 'Aarti Sharma', 'investigatorAffiliation': 'Weill Medical College of Cornell University'}}}}