search
Back to results

RBC Transfusion in Severe Anemia With Lactic Acidosis (TOTAL)

Primary Purpose

Anemia

Status
Completed
Phase
Phase 3
Locations
Uganda
Study Type
Interventional
Intervention
RBC transfusion
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, Transfusion, RBC storage age, Tissue oxygenation, Malaria

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 6 mos to 5 years
  • Hg < 5 g/dL and Lactate > 5 mM

Exclusion Criteria:

  • Receiving transfusion other than RBCs
  • Children with known or suspected cardiac disease

Sites / Locations

  • Mulago Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Short-storage RBC

Prolonged-storage RBC

Arm Description

RBC transfusion using packed RBCs stored for 10 days or less.

RBC transfusion using packed RBCs stored for 25 days or more.

Outcomes

Primary Outcome Measures

Reduction of elevated levels of blood lactate during 24 following RBC transfusion

Secondary Outcome Measures

Normalization of vital signs
Correction of acidosis

Full Information

First Posted
April 25, 2012
Last Updated
April 6, 2016
Sponsor
Massachusetts General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01586923
Brief Title
RBC Transfusion in Severe Anemia With Lactic Acidosis
Acronym
TOTAL
Official Title
A Prospective Study of RBC Transfusion in Children With Severe Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The hypothesis of this study is that prolonged-storage RBCs are not inferior to short-storage RBCs for the time required to clear elevated blood lactate levels in children with severe anemia.
Detailed Description
This study will measure the time to resolution of lactic acidosis in patients with severe anemia following blood transfusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Anemia, Transfusion, RBC storage age, Tissue oxygenation, Malaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short-storage RBC
Arm Type
Active Comparator
Arm Description
RBC transfusion using packed RBCs stored for 10 days or less.
Arm Title
Prolonged-storage RBC
Arm Type
Active Comparator
Arm Description
RBC transfusion using packed RBCs stored for 25 days or more.
Intervention Type
Biological
Intervention Name(s)
RBC transfusion
Intervention Description
RBC transfusion of different storage age
Primary Outcome Measure Information:
Title
Reduction of elevated levels of blood lactate during 24 following RBC transfusion
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Normalization of vital signs
Time Frame
24 hours
Title
Correction of acidosis
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 6 mos to 5 years Hg < 5 g/dL and Lactate > 5 mM Exclusion Criteria: Receiving transfusion other than RBCs Children with known or suspected cardiac disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter H Dzik, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mulago Hospital
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data published
Citations:
PubMed Identifier
26637812
Citation
Dhabangi A, Ainomugisha B, Cserti-Gazdewich C, Ddungu H, Kyeyune D, Musisi E, Opoka R, Stowell CP, Dzik WH. Effect of Transfusion of Red Blood Cells With Longer vs Shorter Storage Duration on Elevated Blood Lactate Levels in Children With Severe Anemia: The TOTAL Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2514-23. doi: 10.1001/jama.2015.13977.
Results Reference
derived

Learn more about this trial

RBC Transfusion in Severe Anemia With Lactic Acidosis

We'll reach out to this number within 24 hrs