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NCT Number: NCT01580111

Effect of Blood Storage Age on the Resolution of Lactic Acidosis in Children With Severe Malarial Anemia at Mulago Hospital

In resolving lactic acidosis among children with severe malarial anemia, there is no difference between those transfused with blood of longer storage compared to shorter storage age

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Key information

Conditions

Compare Blood Age for Transfusion Acid-Base Imbalance Acidosis Acidosis, Lactic Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mulago Hospital

Kampala, Uganda, 256

About this study

Objective of the study is to evaluate the effect of blood storage age on resolution of lactic acidosis in children with severe malarial anemia.

Methods:

Children aged 6 - 59 months admitted to ACU with Severe Malarial Anemia (Hb <5g/dl) and Lactic Acidosis (blood lactate >5 mmol /l), will be randomly assigned to receive either blood of shorter storage age (<10 days) or longer storage age (21 -35 days) by gravity infusion as is the routine practice. 37 patients will be enrolled in each study arm. Physiological measurements namely blood lactate, oxygen saturation, Hemoglobin, Blood pressure, respiratory rate and pulse rate will be taken at baseline, during and after transfusion. The two groups will be compared. The primary outcome variable will be the proportion of children whose lactic acidosis resolves after 4 hrs of transfusion. 24hr mortality will be our secondary outcome.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Children aged 6 - 59 months admitted at Acute care Unit - Mulago hospital with;

  • A positive B/S for malaria
  • Severe anemia ( Hb ≤ 5 g/dl) and
  • Lactic Acidosis (Blood lactate ≥ 5 mmol/l)
  • Written informed consent from the caretaker.

Exclusion criteria

  • Children undergoing transfusion with blood products other than packed cells.
  • Children with known or concurrent cardiac disease.

Treatment and study plan

Blood transfusion

Biological

The short storage arm; children were transfused with packed red cells of storage age 1-10 days; while for the Long storage arm; were transfused with packed red cells of 21- 35 days in storage.

Primary outcomes

  1. Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital

    Time frame: 4hrs

    The proportion of transfused patients who resolve lactic acidosis within 4 hours of transfusion

Secondary outcomes

  1. Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital

    Time frame: 24 HRS

    proportion of children who die within 24 hrs.

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 18, 2012
Registry last updated
Apr 18, 2012

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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