RBC Transfusion in Severe Anemia With Lactic Acidosis (TOTAL)

This study has been completed.
Information provided by (Responsible Party):
Walter H. Dzik, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
First received: April 25, 2012
Last updated: April 6, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Biological: RBC transfusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Study of RBC Transfusion in Children With Severe Anemia

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Reduction of elevated levels of blood lactate during 24 following RBC transfusion [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Normalization of vital signs [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Correction of acidosis [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 290
Study Start Date: February 2013
Study Completion Date: April 2016
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Short-storage RBC
RBC transfusion using packed RBCs stored for 10 days or less.
Biological: RBC transfusion
RBC transfusion of different storage age
Active Comparator: Prolonged-storage RBC
RBC transfusion using packed RBCs stored for 25 days or more.
Biological: RBC transfusion
RBC transfusion of different storage age

Detailed Description:
This study will measure the time to resolution of lactic acidosis in patients with severe anemia following blood transfusion.

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01586923

Mulago Hospital
Kampala, Uganda
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Walter H Dzik, MD Massachusetts General Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Walter H. Dzik, Co-Director, Blood Transfusion Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01586923     History of Changes
Other Study ID Numbers: R21 
Study First Received: April 25, 2012
Last Updated: April 6, 2016
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Massachusetts General Hospital:
RBC storage age
Tissue oxygenation

Additional relevant MeSH terms:
Hematologic Diseases

ClinicalTrials.gov processed this record on May 26, 2016