Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

RBC Transfusion in Severe Anemia With Lactic Acidosis (TOTAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Walter H. Dzik, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01586923
First received: April 25, 2012
Last updated: April 6, 2016
Last verified: April 2016

April 25, 2012
April 6, 2016
February 2013
May 2015   (final data collection date for primary outcome measure)
Reduction of elevated levels of blood lactate during 24 following RBC transfusion [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Proportion of patients who achieve a blood lactate < 2 mM [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01586923 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
RBC Transfusion in Severe Anemia With Lactic Acidosis
A Prospective Study of RBC Transfusion in Children With Severe Anemia
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.
This study will measure the time to resolution of lactic acidosis in patients with severe anemia following blood transfusion.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anemia
Biological: RBC transfusion
RBC transfusion of different storage age
  • Active Comparator: Short-storage RBC
    RBC transfusion using packed RBCs stored for 10 days or less.
    Intervention: Biological: RBC transfusion
  • Active Comparator: Prolonged-storage RBC
    RBC transfusion using packed RBCs stored for 25 days or more.
    Intervention: Biological: RBC transfusion
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
290
April 2016
May 2015   (final data collection date for primary outcome measure)

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
Both
6 Months to 5 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT01586923
R21
Yes
No
Data published
Walter H. Dzik, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Walter H Dzik, MD Massachusetts General Hospital
Massachusetts General Hospital
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP