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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Compare Blood Age for Transfusion

Intervention / Treatment
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* Biological: Blood transfusion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short storage<br>Short storage arm: Will receive blood (Packed red blood cells) of 1 (one) to 10 (ten) days in storage. | Biological: Blood transfusion<br>* 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.<br>|
| Active Comparator: Long storage arm<br>Will be transfused with blood ( packed red cells) of storage age 21- 35 days. | Biological: Blood transfusion<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital | The proportion of transfused patients who resolve lactic acidosis within 4 hours of transfusion | 4hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital | proportion of children who die within 24 hrs. | 24 HRS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age, Blood, Storage, Transfusion, Lactic acidosis