Sickle Cell AnemiaFACTSNCT07094646
Full Assessment of Clinical Transfusion Support
An observational study of Sickle Cell Anemia and Blood Transfusion, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
Trial summary
This study looks at why some children develop very severe anemia that leads to a blood transfusion. It also checks for diseases in the blood they receive. Researchers are using small samples of dried blood (called dried blood spots) from both the children and the donated blood to find out what might be causing the… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Anemia, Blood Transfusion, Malaria Parasitaemia
- How many people
- 250 participants
- Where
- 1 siteUganda
- Study dates
- 21 Sep 2023to 19 Mar 2024
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients receiving a blood transfusion in Eastern Uganda at Jinja Regional Referral Hospital.
Who may be able to join
- Children receiving a blood transfusion in Eastern Uganda at Jinja Regional Referral Hospital.
Who cannot join
- If receiving a blood transfusion, refusal or inability to sign an informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Assessment of Hematologic Diseases Among Blood Transfusion Recipients and Donated Units at a Pediatric Regional Referral Hospital in Uganda
This study looks at why some children develop very severe anemia that leads to a blood transfusion. It also checks for diseases in the blood they receive. Researchers are using small samples of dried blood (called dried blood spots) from both the children and the donated blood to find out what might be causing the anemia.
Read the detailed description
This study includes children at Jinja Regional Referral Hospital (Jinja, Uganda) who need a blood transfusion, whether they are in the clinic, emergency room, or children's ward. After doctors finish the usual blood tests, a small sample of leftover blood will be saved on a special card (called a dried blood spot). The same will be done for all blood transfused during the study. These samples will be frozen and later sent to Cincinnati Children's Hospital for testing.
- Conditions
- Sickle Cell Anemia, Blood Transfusion, Malaria Parasitaemia
- Keywords
- FACTS, JRRH, sickle cell anemia
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Wet Season - Transfusion | Those receiving a blood transfusion during the Eastern Uganda wet season. | |
| Dry Season - Transfusion | Those receiving a blood transfusion during the Eastern Uganda dry season. | |
| Wet Season - Donated | Transfusion units donated during the Eastern Uganda wet season. | |
| Dry Season - Donated | Transfusion units donated during the Eastern Uganda dry season. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Sickle Cell Anemia
How common sickle cell anemia is in children who need a blood transfusion in Eastern Uganda.
Measured: At enrollment.
Secondary outcomes (3)
Frequency of Malaria Parasitemia
How common malaria parasitemia in children needing blood transfusions in Eastern Uganda.
Measured: At enrollment.
Frequency of Iron Deficiency
How often people who get blood transfusions have low iron levels, and the iron levels in the blood that is donated and used for transfusions
Measured: At enrollment
Blood Group Markers
Checking to ensure safe blood matches from donated blood and people receiving blood transfusions.
Measured: At enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start21 Sep 2023
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
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.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Russell E Ware, MD, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094646
- Sponsor's protocol ID
- FACTS
- Acronym
- FACTS
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All samples collected will be de-identified and their collection, storage and analysis constitute no more than minimal risk activities.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of Hematologic Diseases Among Blood Transfusion Recipients and Donated Units at a Pediatric Regional Referral Hospital in Uganda
- ClinicalTrials.gov ID
- NCT07094646
- Acronym / sponsor ID
- FACTS / FACTS
- Conditions
- Sickle Cell Anemia, Blood Transfusion, Malaria Parasitaemia
- Keywords
- FACTS, JRRH, sickle cell anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 30 Jul 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 looks at why some children develop very severe anemia that leads to a blood transfusion. It also checks for diseases in the blood they receive. Researchers are using small samples of dried blood (called dried blood spots) from both the children and the donated blood to find out what might be causing the anemia.
Detailed description
This study includes children at Jinja Regional Referral Hospital (Jinja, Uganda) who need a blood transfusion, whether they are in the clinic, emergency room, or children's ward. After doctors finish the usual blood tests, a small sample of leftover blood will be saved on a special card (called a dried blood spot). The same will be done for all blood transfused during the study. These samples will be frozen and later sent to Cincinnati Children's Hospital for testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Wet Season - Transfusion | – | –Those receiving a blood transfusion during the Eastern Uganda wet season. |
| Dry Season - Transfusion | – | –Those receiving a blood transfusion during the Eastern Uganda dry season. |
| Wet Season - Donated | – | –Transfusion units donated during the Eastern Uganda wet season. |
| Dry Season - Donated | – | –Transfusion units donated during the Eastern Uganda dry season. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving a blood transfusion in Eastern Uganda at Jinja Regional Referral Hospital.
Key inclusion criteria (1 listed)
- Children receiving a blood transfusion in Eastern Uganda at Jinja Regional Referral Hospital.
Key exclusion criteria (1 listed)
- If receiving a blood transfusion, refusal or inability to sign an informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of Sickle Cell Anemia
Time frame: At enrollment.
How common sickle cell anemia is in children who need a blood transfusion in Eastern Uganda.
3 secondary outcomes
Frequency of Malaria Parasitemia
Time frame: At enrollment.
Frequency of Iron Deficiency
Time frame: At enrollment
Blood Group Markers
Time frame: At enrollment.
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 30 Jul 2025.
- Individual participant dataSharing planned: No. All samples collected will be de-identified and their collection, storage and analysis constitute no more than minimal risk activities.
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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.
Russell E Ware, MD, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
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 Blood Transfusion, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
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 1 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: finished, as of the sponsor's last update on 30 Jul 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 Uganda. 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.
What does the primary outcome measure?
Frequency of Sickle Cell Anemia (time frame: At enrollment.). It is what the study was designed to measure, not a finding.
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 30 Jul 2025.