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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01580111
Enrollment
74
Registered
2012-04-18
Start date
2010-12-31
Completion date
2011-11-30
Last updated
2012-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compare Blood Age for Transfusion

Keywords

Blood, Storage, Age, Transfusion, Lactic acidosis

Brief 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.

Interventions

BIOLOGICALBlood transfusion

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.

Sponsors

Makerere University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No

Inclusion criteria

Children aged 6 - 59 months admitted at Acute care Unit - Mulago hospital with; 1. A positive B/S for malaria 2. Severe anemia ( Hb ≤ 5 g/dl) and 3. Lactic Acidosis (Blood lactate ≥ 5 mmol/l) 4. Written informed consent from the caretaker.

Exclusion criteria

1. Children undergoing transfusion with blood products other than packed cells. 2. Children with known or concurrent cardiac disease.

Design outcomes

Primary

MeasureTime frameDescription
Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital4hrsThe proportion of transfused patients who resolve lactic acidosis within 4 hours of transfusion

Secondary

MeasureTime frameDescription
Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital24 HRSproportion of children who die within 24 hrs.

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026