Transfusion in Malaria: Resolution of Lactic Acidosis by Transfusion in Children With Severe Malaria Anemia. (TIM)

This study is currently recruiting participants.
Verified February 2013 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: February 15, 2013
Last verified: February 2013
  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:
  • Proportion of patients who achieve a blood lactate < 2 mM [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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 malaria 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
  • Positive blood smear for malaria

Exclusion Criteria:

  • Receiving transfusion other than RBCs
  • Children with known or suspected cardiac disease
  Contacts and Locations
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: February 15, 2013
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Massachusetts General Hospital:
Malaria
Anemia
Transfusion

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on April 22, 2014