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RBC Transfusion in Severe Anemia With Lactic Acidosis (TOTAL)

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.
ClinicalTrials.gov Identifier: NCT01586923
Recruitment Status : Completed
First Posted : April 27, 2012
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Anemia Biological: RBC transfusion Phase 3

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study of RBC Transfusion in Children With Severe Anemia
Study Start Date : February 2013
Primary Completion Date : May 2015
Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Reduction of elevated levels of blood lactate during 24 following RBC transfusion [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Normalization of vital signs [ Time Frame: 24 hours ]
  2. Correction of acidosis [ Time Frame: 24 hours ]

Eligibility Criteria

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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): NCT01586923


Locations
Uganda
Mulago Hospital
Kampala, Uganda
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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
First Posted: April 27, 2012    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data published

Keywords provided by Walter H. Dzik, Massachusetts General Hospital:
Anemia
Transfusion
RBC storage age
Tissue oxygenation
Malaria

Additional relevant MeSH terms:
Anemia
Hematologic Diseases