Full Assessment of Clinical Transfusion Support

NCT07094646 | Completed

• 1 other identifier: FACTS
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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 anemia.

Conditions

Sickle Cell Anemia; Blood Transfusion; Malaria Parasitaemia

Keywords

FACTS; JRRH; sickle cell anemia

Outcome Measures

Primary Outcomes (1)

• Frequency of Sickle Cell Anemia

  How common sickle cell anemia is in children who need a blood transfusion in Eastern Uganda.

  At enrollment.

Secondary Outcomes (3)

• Frequency of Malaria Parasitemia

  At enrollment.

• Frequency of Iron Deficiency

  At enrollment

• Blood Group Markers

  At enrollment.

Study Arms (4)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving a blood transfusion in Eastern Uganda at Jinja Regional Referral Hospital.

You may qualify if:

• Children receiving a blood transfusion in Eastern Uganda at Jinja Regional Referral Hospital.

You may not qualify if:

• If receiving a blood transfusion, refusal or inability to sign an informed consent.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Cincinnati Children's Hospital Medical Center (CCHMC): collaborator

Study Sites (1)

Jinja Regional Referral Hospital (JRRH)

Jinja, Uganda

Location

Biospecimen

Retention: SAMPLES WITH DNA

Dried Blood Spots

MeSH Terms

Conditions

Anemia, Sickle Cell

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

Study Officials

• Russell E Ware, MD, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: September 21, 2023
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)