RBC Transfusion in Severe Anemia With Lactic Acidosis

Phase 3

Completed

• Conditions: Anemia
• Interventions: Biological: RBC transfusion

• Registration Number: NCT01586923
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-04-25
• Study First Posted: 2012-04-27
• Study Start: 2013-02
• Primary Completion: 2015-05
• Status Verified: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-06
• Last Update Posted: 2016-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prolonged-storage RBC	RBC transfusion	RBC transfusion using packed RBCs stored for 25 days or more.
Short-storage RBC	RBC transfusion	RBC transfusion using packed RBCs stored for 10 days or less.

Primary Outcome Measures

Name	Time	Method
Reduction of elevated levels of blood lactate during 24 following RBC transfusion	24 hours

Secondary Outcome Measures

Name	Time	Method
Correction of acidosis	24 hours
Normalization of vital signs	24 hours

Trial Locations

Locations (1)

Mulago Hospital; 🇺🇬 Kampala, Uganda