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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01580111
First Posted: April 18, 2012
Last Update Posted: April 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Faculty of Medicine, Makerere University
  Purpose
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

Condition Intervention
Compare Blood Age for Transfusion Biological: Blood transfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Blood Storage Age on the Resolution of Lactic Acidosis in Children With Severe Malarial Anemia at Mulago Hospital

Resource links provided by NLM:


Further study details as provided by Faculty of Medicine, Makerere University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 74
Study Start Date: December 2010
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Short storage
Short storage arm: Will receive blood (Packed red blood cells) of 1 (one) to 10 (ten) days in storage.
Biological: Blood 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.
Active Comparator: Long storage arm
Will be transfused with blood ( packed red cells) of storage age 21- 35 days.
Biological: Blood 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.

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.

  Eligibility

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580111


Locations
Uganda
Mulago Hospital
Kampala, Uganda, 256
Sponsors and Collaborators
Makerere University
Investigators
Principal Investigator: AGGREY DHABANGI, MBChB, M.Med Makerere University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Faculty of Medicine, Teaching Assistant, Makerere University
ClinicalTrials.gov Identifier: NCT01580111     History of Changes
Other Study ID Numbers: AD-001
First Submitted: April 17, 2012
First Posted: April 18, 2012
Last Update Posted: April 18, 2012
Last Verified: April 2012

Keywords provided by Faculty of Medicine, Makerere University:
Blood
Storage
Age
Transfusion
Lactic acidosis

Additional relevant MeSH terms:
Acidosis
Acidosis, Lactic
Acid-Base Imbalance
Metabolic Diseases