NCT01586923

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

2.2 years

First QC Date

April 25, 2012

Last Update Submit

April 6, 2016

Conditions

Anemia

Keywords

AnemiaTransfusionRBC storage ageTissue oxygenationMalaria

Outcome Measures

Primary Outcomes (1)

  • Reduction of elevated levels of blood lactate during 24 following RBC transfusion

    24 hours

Secondary Outcomes (2)

  • Normalization of vital signs

    24 hours

  • Correction of acidosis

    24 hours

Study Arms (2)

Short-storage RBC

ACTIVE COMPARATOR

RBC transfusion using packed RBCs stored for 10 days or less.

Biological: RBC transfusion

Prolonged-storage RBC

ACTIVE COMPARATOR

RBC transfusion using packed RBCs stored for 25 days or more.

Biological: RBC transfusion

Interventions

RBC transfusionBIOLOGICAL

RBC transfusion of different storage age

Prolonged-storage RBCShort-storage RBC

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 6 mos to 5 years
  • Hg \< 5 g/dL and Lactate \> 5 mM

You may not qualify if:

  • Receiving transfusion other than RBCs
  • Children with known or suspected cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulago Hospital

Kampala, Uganda

Location

Related Publications (1)

  • 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.

    PMID: 26637812DERIVED

MeSH Terms

Conditions

AnemiaMalaria

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Walter H Dzik, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director, Blood Transfusion Service

Study Record Dates

First Submitted

April 25, 2012

First Posted

April 27, 2012

Study Start

February 1, 2013

Primary Completion

May 1, 2015

Study Completion

April 1, 2016

Last Updated

April 8, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Data published

Locations

UG(1)