Clinical Trials Directory

Trials / Completed

CompletedNCT01580111

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
74 (actual)
Sponsor
Makerere University · Academic / Other
Sex
All
Age
6 Months – 59 Months
Healthy volunteers
Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALBlood transfusionThe 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.

Timeline

Start date
2010-12-01
Primary completion
2011-08-01
Completion
2011-11-01
First posted
2012-04-18
Last updated
2012-04-18

Locations

1 site across 1 country: Uganda

Source: ClinicalTrials.gov record NCT01580111. Inclusion in this directory is not an endorsement.