Sickle Cell DiseaseNCT07200869
Outcomes of Vaso-occlusive Crisis in Pediatric Sickle Cell Disease
An observational study of Sickle Cell Disease and Vaso-occlusive Crisis, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Sickle Cell Disease, Vaso-occlusive Crisis
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2025to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Patients with other hemoglobinopathies (e.g., thalassemia). Patients with incomplete medical records. Children with coexisting chronic diseases that may confound pain crises .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Assiut University research office contact
About this study
Official title: Vaso-occlusive Crisis Incidence and Outcomes in a Pediatric Sickle Cell Population
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.
Read the 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.
- Conditions
- Sickle Cell Disease, Vaso-occlusive Crisis
- Being tested
- No intervention
- Keywords
- Pediatric, Sickle Cell Anemia, Incidence, Outcomes
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sickle Cell pediatric patients | Children with sickle cell disease whose medical records will be retrospectively reviewed at Assiut University Hospital. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Complications related to vaso-occlusive crisis will be identified and documented from patient records.
Measured: Throughout the study period (2019-2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Fawzy Fahmy Hanna, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200869
- Sponsor's protocol ID
- Pediatric sickle cell crises
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 10861320Powars 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.
PubMed 16267411Platt 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.
PubMed 1710777Serjeant GR. The natural history of sickle cell disease. Cold Spring Harb Perspect Med. 2013 Oct 1;3(10):a011783. doi: 10.1101/cshperspect.a011783.
PubMed 23813607El-Beshlawy A, Youssry I. Prevention of hemoglobinopathies in Egypt. Hemoglobin. 2009;33 Suppl 1:S14-20. doi: 10.3109/03630260903346395.
PubMed 20001619Piel 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.
PubMed 23874164Rees 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.
PubMed 21131035
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaso-occlusive Crisis Incidence and Outcomes in a Pediatric Sickle Cell Population
- ClinicalTrials.gov ID
- NCT07200869
- Acronym / sponsor ID
- Pediatric sickle cell crises
- Conditions
- Sickle Cell Disease, Vaso-occlusive Crisis
- Keywords
- Pediatric, Sickle Cell Anemia, Incidence, Outcomes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sickle Cell pediatric patients | – | Other: No interventionChildren with sickle cell disease whose medical records will be retrospectively reviewed at Assiut University Hospital. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with other hemoglobinopathies (e.g., thalassemia). Patients with incomplete medical records. Children with coexisting chronic diseases that may confound pain crises .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionretrospective observational study. No intervention will be administered; data will be collected from existing medical records of pediatric sickle cell patients at Assiut University Hospital. | Other | Sickle Cell pediatric patients |
Primary outcome
Incidence of vaso-occlusive crisis in pediatric sickle cell patients
Time frame: Retrospective review of medical records from 2019 to 2024
Frequency of vaso-occlusive crisis episodes will be identified through retrospective chart review of pediatric sickle cell patients.
1 secondary outcome
Complications associated with vaso-occlusive crisis (e.g., acute chest syndrome, stroke, infections)
Time frame: Throughout the study period (2019-2024)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Results publication: PubMed 10861320Vichinsky 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.
- Results publication: PubMed 16267411Powars 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.
- Results publication: PubMed 1710777Platt 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.
- Results publication: PubMed 23813607Serjeant GR. The natural history of sickle cell disease. Cold Spring Harb Perspect Med. 2013 Oct 1;3(10):a011783. doi: 10.1101/cshperspect.a011783.
- Results publication: PubMed 20001619El-Beshlawy A, Youssry I. Prevention of hemoglobinopathies in Egypt. Hemoglobin. 2009;33 Suppl 1:S14-20. doi: 10.3109/03630260903346395.
- Results publication: PubMed 23874164Piel 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.
- Results publication: PubMed 21131035Rees 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Assiut University research office contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and Vaso-occlusive Crisis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadia Fawzy, Pediatrician (+201552865958 ext. +201552865958, Nadiafawzy730@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of vaso-occlusive crisis in pediatric sickle cell patients (time frame: Retrospective review of medical records from 2019 to 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07200869, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.