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Not yet recruiting NCT07200869

Outcomes of Vaso-occlusive Crisis in Pediatric Sickle Cell Disease

— Observational Sickle Cell Disease Vaso-occlusive Crisis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Sickle Cell Disease, Vaso-occlusive Crisis. Basic parameters: 1 year — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Vaso-occlusive Crisis Incidence and Outcomes in a Pediatric Sickle Cell Population

Overview

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.

Detailed description

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.

This 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.

Interventions

  • Other No intervention
    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.

Primary outcome measures

  • Incidence of vaso-occlusive crisis in pediatric sickle cell patients [Time frame: Retrospective review of medical records from 2019 to 2024]
Secondary outcome measures (1)
  • Complications associated with vaso-occlusive crisis (e.g., acute chest syndrome, stroke, infections) [Time frame: Throughout the study period (2019-2024)]

Eligibility criteria

Inclusion criteria

  • Children aged 1-18 years. Confirmed diagnosis of sickle cell anemia by hemoglobin electrophoresis or high-performance liquid chromatography .

History of at least one hospital visit or admission for vaso-occlusive crisis

Exclusion criteria

  • Patients with other hemoglobinopathies (e.g., thalassemia). Patients with incomplete medical records. Children with coexisting chronic diseases that may confound pain crises .

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Assiut University — Asyut

Publications

  • 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 10861320
  • 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 16267411
  • 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 1710777
  • 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 23813607
  • El-Beshlawy A, Youssry I. Prevention of hemoglobinopathies in Egypt. Hemoglobin. 2009;33 Suppl 1:S14-20. doi: 10.3109/03630260903346395. PMID 20001619
  • 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 23874164
  • 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. PMID 21131035

Identifiers

NCT: NCT07200869 · Pediatric sickle cell crises

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗