Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT07200869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes of Vaso-occlusive Crisis in Pediatric Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D000098644', 'term': 'Vaso-Occlusive Crises'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of vaso-occlusive crisis in pediatric sickle cell patients', 'timeFrame': 'Retrospective review of medical records from 2019 to 2024', 'description': 'Frequency of vaso-occlusive crisis episodes will be identified through retrospective chart review of pediatric sickle cell patients.'}], 'secondaryOutcomes': [{'measure': 'Complications associated with vaso-occlusive crisis (e.g., acute chest syndrome, stroke, infections)', 'timeFrame': 'Throughout the study period (2019-2024)', 'description': 'Complications related to vaso-occlusive crisis will be identified and documented from patient records.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric', 'Sickle Cell Anemia', 'Incidence', 'Outcomes'], 'conditions': ['Sickle Cell Disease', 'Vaso-occlusive Crisis']}, 'referencesModule': {'references': [{'pmid': '10861320', 'type': 'BACKGROUND', 'citation': 'Vichinsky EP, Neumayr LD, Earles AN, Williams R, Lennette ET, Dean D, Nickerson B, Orringer E, McKie V, Bellevue R, Daeschner C, Manci EA. Causes and outcomes of the acute chest syndrome in sickle cell disease. National Acute Chest Syndrome Study Group. N Engl J Med. 2000 Jun 22;342(25):1855-65. doi: 10.1056/NEJM200006223422502.'}, {'pmid': '16267411', 'type': 'BACKGROUND', 'citation': 'Powars DR, Chan LS, Hiti A, Ramicone E, Johnson C. Outcome of sickle cell anemia: a 4-decade observational study of 1056 patients. Medicine (Baltimore). 2005 Nov;84(6):363-376. doi: 10.1097/01.md.0000189089.45003.52.'}, {'pmid': '1710777', 'type': 'BACKGROUND', 'citation': 'Platt OS, Thorington BD, Brambilla DJ, Milner PF, Rosse WF, Vichinsky E, Kinney TR. Pain in sickle cell disease. Rates and risk factors. N Engl J Med. 1991 Jul 4;325(1):11-6. doi: 10.1056/NEJM199107043250103.'}, {'pmid': '23813607', 'type': 'BACKGROUND', 'citation': 'Serjeant GR. The natural history of sickle cell disease. Cold Spring Harb Perspect Med. 2013 Oct 1;3(10):a011783. doi: 10.1101/cshperspect.a011783.'}, {'pmid': '20001619', 'type': 'BACKGROUND', 'citation': 'El-Beshlawy A, Youssry I. Prevention of hemoglobinopathies in Egypt. Hemoglobin. 2009;33 Suppl 1:S14-20. doi: 10.3109/03630260903346395.'}, {'pmid': '23874164', 'type': 'BACKGROUND', 'citation': 'Piel FB, Hay SI, Gupta S, Weatherall DJ, Williams TN. Global burden of sickle cell anaemia in children under five, 2010-2050: modelling based on demographics, excess mortality, and interventions. PLoS Med. 2013;10(7):e1001484. doi: 10.1371/journal.pmed.1001484. Epub 2013 Jul 16.'}, {'pmid': '21131035', 'type': 'BACKGROUND', 'citation': 'Rees DC, Williams TN, Gladwin MT. Sickle-cell disease. Lancet. 2010 Dec 11;376(9757):2018-31. doi: 10.1016/S0140-6736(10)61029-X. Epub 2010 Dec 3.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the incidence and clinical outcomes of vaso-occlusive crises in pediatric patients with sickle cell disease. Data will be collected and analyzed to identify risk factors and related complications.', 'detailedDescription': 'Sickle cell disease is a hereditary blood disorder characterized by the presence of sickle-shaped red blood cells, which leads to recurrent vaso-occlusive crises (VOC). These painful episodes are among the most common causes of hospitalization and are associated with significant morbidity in pediatric patients. Despite ongoing improvements in the management of sickle cell disease, there is still limited data describing the incidence, risk factors, and clinical outcomes of VOC in children within our population.\n\nThis study is designed to retrospectively analyze medical records of pediatric patients with sickle cell disease at Faculty of Medicine, Assiut University. The primary aim is to estimate the incidence of vaso-occlusive crises and to identify the most frequent complications. Secondary objectives include evaluating treatment approaches, length of hospital stay, and clinical outcomes. Findings from this study are expected to provide valuable insights that may help improve clinical care strategies and preventive measures for affected children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients (1-18 years) with confirmed Sickle Cell Disease. The study observes the incidence and outcomes of vaso-occlusive crises (VOCs). Both sexes are eligible. Healthy volunteers are not included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 1-18 years. Confirmed diagnosis of sickle cell anemia by hemoglobin electrophoresis or high-performance liquid chromatography .\n\nHistory of at least one hospital visit or admission for vaso-occlusive crisis\n\nExclusion Criteria:\n\n* Patients with other hemoglobinopathies (e.g., thalassemia). Patients with incomplete medical records. Children with coexisting chronic diseases that may confound pain crises .'}, 'identificationModule': {'nctId': 'NCT07200869', 'briefTitle': 'Outcomes of Vaso-occlusive Crisis in Pediatric Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Vaso-occlusive Crisis Incidence and Outcomes in a Pediatric Sickle Cell Population', 'orgStudyIdInfo': {'id': 'Pediatric sickle cell crises'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sickle Cell pediatric patients', 'description': 'Children with sickle cell disease whose medical records will be retrospectively reviewed at Assiut University Hospital.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'retrospective observational study. No intervention will be administered; data will be collected from existing medical records of pediatric sickle cell patients at Assiut University Hospital.', 'armGroupLabels': ['Sickle Cell pediatric patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Nadia Fawzy, Pediatrician', 'role': 'CONTACT', 'email': 'Nadiafawzy730@gmail.com', 'phone': '+201552865958', 'phoneExt': '+201552865958'}, {'name': 'Assiut University research office', 'role': 'CONTACT', 'email': 'pr.med@aun.edu.eg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Nadia Fawzy Fahmy Hanna', 'investigatorAffiliation': 'Assiut University'}}}}