Status:
RECRUITING
Discarded Bone Marrow for Hematology Research
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Hemoglobinopathies
Eligibility:
All Genders
Brief Summary
The primary objective of this study is to establish a mechanism to obtain discarded bone marrow-containing bone samples from hemoglobinopathy, as well as non-hemoglobinopathy individuals. The processi...
Detailed Description
The hemoglobinopathies (e.g. sickle cell disease (SCD) and thalassemia) are devastating inherited anemias that shorten and reduce quality of life. The only current curative therapy for SCD is bone mar...
Eligibility Criteria
Inclusion
- Patients of any age receiving orthopedic surgery for clinical management that involve bone marrow containing bone discard.
- Patients receiving orthopedic surgery for clinical management will be considered for this study if they have the following diagnosis and criteria:
- Homozygous S/S disease or doubly heterozygous for S and β thalassemia who are two years or older are eligible.
- HbE-β- thalassemia or homozygous (severe) β-thalassemia. including those who are transfusion dependent (major) or severely anemic but relatively transfusion independent (intermedia). Diagnostic criteria include standard hematological parameters, red cell indices, hemoglobin electrophoresis and quantitative determination of HbF and HbA2.
Exclusion
- Active, acute manifestations of sickle cell disease including painful crisis, acute chest syndrome, cerebrovascular events or active infection.
- Pregnant women will not be eligible for study enrollment
- Inability or unwillingness of the research participant or legal guardian/representative to give written informed consent will preclude enrollment on this research protocol.
- Platelet count \< 150,000/mm\^3
- Neutrophil count \< 2000/mm\^3
- Neutrophil count \< 1000/mm\^3 for patients on hydroxyurea therapy
- Prothrombin Time \> 17 seconds
- Partial thromboplastin Time \> 43 seconds
- History of excessive bleeding in the context of previous procedures including surgery and dental extractions
Key Trial Info
Start Date :
July 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2035
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04671212
Start Date
July 26 2022
End Date
January 1 2035
Last Update
November 7 2025
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105