Sickle Cell AnemiaNCT00736060
Clinical and Laboratory Characteristics of Sickle Cell Anemia Patients Admitted With Fever
An observational study of Sickle Cell Anemia and Sickle Cell Thalassemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
This study will summarized the clinical and laboratory data and the outcome of all the patients suffering from Sickle Cell Anemia (Including Sickle cell thalassemia) admitted to the pediatric ward. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sickle Cell Anemia, Sickle Cell Thalassemia
- What is being tested?
- Observational
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- May 2008to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 60 patients treated at the Pediatric Hematology Unit in the Ha'Emek Medical Center suffering from sickle cell anemia or sickle cell thalassemia admitted with fever as the presenting symptom.
Inclusion Criteria: All patients admitted with fever as the only presenting symptom.
Exclusion Criteria: Patients admitted with another causes related or unrelated to sickle cell disease and have also fever.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pediatric Hematology Unit - Ha'Emek Medical Center
Afula, Afula, 18101
About this study
Official title: Study the Clinical and Laboratory Characteristics and the Outcome of Sickle Cell Anemia Patients Admitted to the Pediatric Ward Because of Fever as the Presenting Symptom
This study will summarized the clinical and laboratory data and the outcome of all the patients suffering from Sickle Cell Anemia (Including Sickle cell thalassemia) admitted to the pediatric ward.
Read the detailed description
The actual protocol for SCA patients admitted with fever is to obtain blood cultures and start empiric antibiotic treatment.
The study cohort included 60 SCA patients actually treated in the Pediatric Hematology Unit.
- Conditions
- Sickle Cell Anemia, Sickle Cell Thalassemia
- Being tested
- Observational
- Keywords
- Fever, Blood cultures
- Medical subject headings
- Anemia, Sickle Cell, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Summary of clinical and laboratory data
| Study group | Role | What they receive |
|---|---|---|
| 1 | Sickle cell anemia Receives: Other: Observational | |
| 2 | Sickle cell thalassemia Receives: Other: Observational |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startMay 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
- 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
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Koren Ariel, HaEmek Medical Center, Israel
- Investigators
- Carina Levin, MD, Principal investigator, Pediatric Hematology Unit - Ha'Emek Medical Center - Afula - 18101 - IsraelIlena Arshinov, MD, Principal investigator, Pediatric Dpt B - Ha'Emek Medical Center - Afula - Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736060
- Sponsor's protocol ID
- 0027-08-EMC
- Status last verified
- Aug 2011
- First submitted
- 14 Aug 2008
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Clinical and Laboratory Characteristics and the Outcome of Sickle Cell Anemia Patients Admitted to the Pediatric Ward Because of Fever as the Presenting Symptom
- ClinicalTrials.gov ID
- NCT00736060
- Acronym / sponsor ID
- 0027-08-EMC
- Conditions
- Sickle Cell Anemia, Sickle Cell Thalassemia
- Keywords
- Fever, Blood cultures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- May 2008
- Study completion
- Nov 2008 (actual)
- First posted
- 15 Aug 2008 (estimated)
- 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 will summarized the clinical and laboratory data and the outcome of all the patients suffering from Sickle Cell Anemia (Including Sickle cell thalassemia) admitted to the pediatric ward.
Detailed description
The actual protocol for SCA patients admitted with fever is to obtain blood cultures and start empiric antibiotic treatment.
The study cohort included 60 SCA patients actually treated in the Pediatric Hematology Unit.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: ObservationalSickle cell anemia |
| 2 | – | Other: ObservationalSickle cell thalassemia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 60 patients treated at the Pediatric Hematology Unit in the Ha'Emek Medical Center suffering from sickle cell anemia or sickle cell thalassemia admitted with fever as the presenting symptom.
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 |
|---|---|---|
| ObservationalSummary of clinical and laboratory data | Other | 1, 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2011.
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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. This study is not recruiting at the moment.
Carina Levin, MD principal investigator
Pediatric Hematology Unit - Ha'Emek Medical Center - Afula - 18101 - Israel
Ilena Arshinov, MD principal investigator
Pediatric Dpt B - Ha'Emek Medical Center - Afula - Israel
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 Anemia and Sickle Cell Thalassemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2011. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 26 Aug 2011.