RBC Transfusion in Severe Anemia With Lactic Acidosis (TOTAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Walter H. Dzik, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01586923
First received: April 25, 2012
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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
Anemia
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 ]

Estimated Enrollment: 250
Study Start Date: February 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 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.

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Walter H Dzik, MD +1-617-726-3715 sdzik@partners.org

Locations
Uganda
Mulago Hospital Recruiting
Kampala, Uganda
Contact: Walter H Dzik, MD    +1-617-726-3715    sdzik@partners.org   
Principal Investigator: Aggrey Dhabangi, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Walter H Dzik, MD Massachusetts General Hospital
  More Information

No publications provided

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: June 17, 2014
Health Authority: Uganda: National Council for Science and Technology

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

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014