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RBC Transfusion in Severe Anemia With Lactic Acidosis

A Prospective Study of RBC Transfusion in Children With Severe Anemia

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01586923
Acronym
TOTAL
Enrollment
290
Registered
2012-04-27
Start date
2013-02-28
Completion date
2016-04-30
Last updated
2016-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

Anemia, Transfusion, RBC storage age, Tissue oxygenation, Malaria

Brief summary

The hypothesis of this study is that prolonged-storage RBCs are not inferior to short-storage RBCs for the time required to clear elevated blood lactate levels in children with severe anemia.

Detailed description

This study will measure the time to resolution of lactic acidosis in patients with severe anemia following blood transfusion.

Interventions

BIOLOGICALRBC transfusion

RBC transfusion of different storage age

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No

Inclusion criteria

* Age 6 mos to 5 years * Hg \< 5 g/dL and Lactate \> 5 mM

Exclusion criteria

* Receiving transfusion other than RBCs * Children with known or suspected cardiac disease

Design outcomes

Primary

MeasureTime frame
Reduction of elevated levels of blood lactate during 24 following RBC transfusion24 hours

Secondary

MeasureTime frame
Normalization of vital signs24 hours
Correction of acidosis24 hours

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026