Outcomes of Vaso-occlusive Crisis in Pediatric Sickle Cell Disease

NCT07200869 | Not Yet Recruiting

• 1 other identifier: Pediatric sickle cell crises
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sickle Cell Disease; Vaso-occlusive Crisis

Keywords

Pediatric; Sickle Cell Anemia; Incidence; Outcomes

Outcome Measures

Primary Outcomes (1)

• Incidence of vaso-occlusive crisis in pediatric sickle cell patients

  Frequency of vaso-occlusive crisis episodes will be identified through retrospective chart review of pediatric sickle cell patients.

  Retrospective review of medical records from 2019 to 2024

Secondary Outcomes (1)

• Complications associated with vaso-occlusive crisis (e.g., acute chest syndrome, stroke, infections)

  Throughout the study period (2019-2024)

Study Arms (1)

Sickle Cell pediatric patients

Children with sickle cell disease whose medical records will be retrospectively reviewed at Assiut University Hospital.

Other: No intervention

Interventions

No intervention OTHER

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.

Sickle Cell pediatric patients

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• El-Beshlawy A, Youssry I. Prevention of hemoglobinopathies in Egypt. Hemoglobin. 2009;33 Suppl 1:S14-20. doi: 10.3109/03630260903346395.

  PMID: 20001619 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Nadia Fawzy, Pediatrician

CONTACT

+201552865958; Nadiafawzy730@gmail.com

Assiut University research office

CONTACT

pr.med@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

EG (1)