RBC Transfusion in Severe Anemia With Lactic Acidosis

NCT ID: NCT01586923

Last Updated: 2016-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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This study will measure the time to resolution of lactic acidosis in patients with severe anemia following blood transfusion.

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Short-storage RBC

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

Group Type ACTIVE_COMPARATOR

RBC transfusion

Intervention Type BIOLOGICAL

RBC transfusion of different storage age

Prolonged-storage RBC

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

Group Type ACTIVE_COMPARATOR

RBC transfusion

Intervention Type BIOLOGICAL

RBC transfusion of different storage age

Interventions

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RBC transfusion

RBC transfusion of different storage age

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Walter H. Dzik

Co-Director, Blood Transfusion Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walter H Dzik, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Mulago Hospital

Kampala, , Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type DERIVED
PMID: 26637812 (View on PubMed)

Other Identifiers

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R21

Identifier Type: -

Identifier Source: org_study_id

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