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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:
Information provided by (Responsible Party):
Faculty of Medicine, Makerere University
ClinicalTrials.gov Identifier:
NCT01580111
First received: April 17, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Makerere University

Additional 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
Study First Received: April 17, 2012
Last Updated: April 17, 2012
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Makerere University:
Blood
Storage
Age
Transfusion
Lactic acidosis

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

ClinicalTrials.gov processed this record on May 16, 2013