Back to results

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

Primary Purpose

Compare Blood Age for Transfusion

Status

Completed

Phase

Not Applicable

Locations

Uganda

Study Type

Interventional

Intervention

Blood transfusion

About this trial

This is an interventional treatment trial for Compare Blood Age for Transfusion focused on measuring Blood, Storage, Age, Transfusion, Lactic acidosis

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mulago Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Short storage

Long storage arm

Arm Description

Short storage arm: Will receive blood (Packed red blood cells) of 1 (one) to 10 (ten) days in storage.

Will be transfused with blood ( packed red cells) of storage age 21- 35 days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01580111

First Posted

April 17, 2012

Last Updated

April 17, 2012

Sponsor

Makerere University

1. Study Identification

Unique Protocol Identification Number

NCT01580111

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Makerere University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Compare Blood Age for Transfusion

Keywords

Blood, Storage, Age, Transfusion, Lactic acidosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Short storage

Arm Type

Experimental

Arm Description

Short storage arm: Will receive blood (Packed red blood cells) of 1 (one) to 10 (ten) days in storage.

Arm Title

Long storage arm

Arm Type

Active Comparator

Arm Description

Will be transfused with blood ( packed red cells) of storage age 21- 35 days.

Intervention Type

Biological

Intervention Name(s)

Blood transfusion

Intervention Description

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.

Primary Outcome Measure Information:

Title

Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital

Description

The proportion of transfused patients who resolve lactic acidosis within 4 hours of transfusion

Time Frame

4hrs

Secondary Outcome Measure Information:

Title

Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital

Description

proportion of children who die within 24 hrs.

Time Frame

24 HRS

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

59 Months

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AGGREY DHABANGI, MBChB, M.Med

Organizational Affiliation

Makerere University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mulago Hospital

City

Kampala

ZIP/Postal Code

256

Country

Uganda

12. IPD Sharing Statement

Citations:

PubMed Identifier

23388470

Citation

Dhabangi A, Mworozi E, Lubega IR, Cserti-Gazdewich CM, Maganda A, Dzik WH. The effect of blood storage age on treatment of lactic acidosis by transfusion in children with severe malarial anaemia: a pilot, randomized, controlled trial. Malar J. 2013 Feb 6;12:55. doi: 10.1186/1475-2875-12-55.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs