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TOTAL: RBC Transfusion Storage Duration in Children with Severe Anemia
NCT01586923Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2013
- Primary completion
- May 2015
- Countries
- 1
- Sponsor
- Massachusetts General Hospital
- Modality
- Recombinant Proteins and Enzymes, Cell Therapies
- Drugs
- red blood cells
- Conditions
- anemia
01
Overview
Phase 3, randomised, double-blind trial of red blood cells in anemia, sponsored by Massachusetts General Hospital. Primary endpoint: Reduction of elevated levels of blood lactate at 24 hours. Started Feb 2013; status: completed.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Children aged 6 months to 5 years with severe anemia (Hg < 5 g/dL) and lactic acidosis (Lactate > 5 mM), excluding those with cardiac disease or receiving other transfusions.
04
Endpoints
Primary
Reduction of elevated levels of blood lactate
Secondary
Normalization of vital signs
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