RBC Transfusion in Severe Anemia With Lactic Acidosis (TOTAL)

Mass General Brigham

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Biological: RBC transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01586923

R21

Details and patient eligibility

About

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.

Full description

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

Enrollment: 290 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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290 participants in 2 patient groups

Short-storage RBC

Active Comparator group

Description:

RBC transfusion using packed RBCs stored for 10 days or less.

Treatment:

Biological: RBC transfusion

Prolonged-storage RBC

Active Comparator group

Description:

RBC transfusion using packed RBCs stored for 25 days or more.

Treatment:

Biological: RBC transfusion