- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01586923
RBC Transfusion in Severe Anemia With Lactic Acidosis (TOTAL)
April 6, 2016 updated by: Walter H. Dzik, Massachusetts General Hospital
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.
Study Overview
Detailed Description
This study will measure the time to resolution of lactic acidosis in patients with severe anemia following blood transfusion.
Study Type
Interventional
Enrollment (Actual)
290
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kampala, Uganda
- Mulago Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Short-storage RBC
RBC transfusion using packed RBCs stored for 10 days or less.
|
RBC transfusion of different storage age
|
Active Comparator: Prolonged-storage RBC
RBC transfusion using packed RBCs stored for 25 days or more.
|
RBC transfusion of different storage age
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of elevated levels of blood lactate during 24 following RBC transfusion
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Normalization of vital signs
Time Frame: 24 hours
|
24 hours
|
Correction of acidosis
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Walter H Dzik, MD, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
April 25, 2012
First Submitted That Met QC Criteria
April 25, 2012
First Posted (Estimate)
April 27, 2012
Study Record Updates
Last Update Posted (Estimate)
April 8, 2016
Last Update Submitted That Met QC Criteria
April 6, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data published
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anemia
-
SanofiActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)United States, Austria, China, Denmark, Germany, Hungary, Italy, Spain, United Kingdom
-
SanofiTerminatedWarm Autoimmune Hemolytic Anemia (wAIHA)United Kingdom, Belgium, Netherlands, France, United States, Germany, Hungary, Italy
-
Abdelwahed, Mai Mahmoud Mohamed, M.D.UnknownAnemia During PregnancyEgypt
-
University of California, DavisInstituto Mexicano del Seguro Social; Thrasher Research Fund; Mexican National... and other collaboratorsCompleted
-
Hospital Universitario Dr. Jose E. GonzalezCompletedPernicious Anemia | Megaloblastic Anemia NosMexico
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingSevere Aplastic Anemia | Idiopathic Aplastic Anemia | Moderate Aplastic Anemia Requiring Transfusions
-
Peking Union Medical College HospitalRecruiting
-
Alexion PharmaceuticalsWithdrawnWarm Autoimmune Hemolytic AnemiaUnited States
-
Alexion PharmaceuticalsTerminatedWarm Autoimmune Hemolytic AnemiaUnited States, Jordan
Clinical Trials on RBC transfusion
-
Daping Hospital and the Research Institute of Surgery...Children's Hospital of Chongqing Medical UniversityWithdrawnAnemia | Necrotizing Enterocolitis | Red Blood Cell (RBC) TransfusionChina
-
University of North Carolina, Chapel HillDuke UniversityWithdrawnSickle Cell Disease | Pulmonary Hypertension
-
Ottawa Hospital Research InstituteCanadian Institutes of Health Research (CIHR); Canadian Blood ServicesActive, not recruitingRed Blood Cell TransfusionCanada
-
University of EdinburghNHS Lothian; Chief Scientist Office of the Scottish Government; Transfusion Medicine...CompletedAnemia | Blood Transfusion | Intensive CareUnited Kingdom
-
Mayo ClinicCompletedBlood Protein Disorders | Pulmonary EdemasUnited States
-
McMaster UniversityCBSRecruitingMyelodysplastic SyndromeCanada
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedTransfusion-associated Circulatory Overload | Blood Transfusion ReactionNetherlands
-
WestatEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingSickle Cell Disease | Thalassemia | Pediatric CancerUnited States, Brazil
-
Beth Israel Deaconess Medical CenterAmerican Heart AssociationTerminatedAnemia | Acute Coronary SyndromeUnited States
-
Emory UniversityTerminated