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Completed

NCT Number: NCT01586923

RBC Transfusion in Severe Anemia With Lactic Acidosis

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mulago Hospital

Kampala, Uganda

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RBC transfusion

Biological

RBC transfusion of different storage age

Primary outcomes

  1. Reduction of elevated levels of blood lactate during 24 following RBC transfusion

    Time frame: 24 hours

Secondary outcomes

  1. Normalization of vital signs

    Time frame: 24 hours

  2. Correction of acidosis

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

A Prospective Study of RBC Transfusion in Children With Severe Anemia

Acronym: TOTAL

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Apr 27, 2012
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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