Clinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-12-31

Brief Summary

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The trial will evaluate the efficacy of the Mirasol Pathogen Reduction Technology for Whole Blood to prevent Malaria transmission by transfusion of whole blood.

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Detailed Description

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Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mirasol

Transfusions with Mirasol-treated whole blood

Group Type EXPERIMENTAL

Mirasol-treated Whole Blood

Intervention Type DEVICE

Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood

Control

Transfusions with untreated whole blood

Group Type ACTIVE_COMPARATOR

Untreated Whole Blood

Intervention Type BIOLOGICAL

Transfusion with untreated fresh Whole Blood

Interventions

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Mirasol-treated Whole Blood

Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood

Intervention Type DEVICE

Untreated Whole Blood

Transfusion with untreated fresh Whole Blood

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Patient is blood group O+
* Anticipated to be hospitalized for at least 3 consecutive days after initial study transfusion
* Expected to require no more than 2 units of Fresh Whole Blood in the 3 days following randomization
* Agree to return to the hospital for the follow-up visits
* Women of Child Bearing Potential must have a negative pregnancy test within 72 hours before randomization when warranted and must agree to practice a medically acceptable contraception regimen or agree to abstain from heterosexual intercourse during their study participation.
* Patient or legally authorized representative has given written informed consent

Exclusion Criteria

* Symptoms of clinical malaria (confirmed by microscopy)
* Patient has received antimalarial treatment within 7 days prior to randomization
* Fever (Central body temperature greater than 38.5°C)
* Massive bleeding expected to require more than two Fresh Whole Blood units within 3 days from randomization
* Transfusion(s) of a blood product within 1 month prior to randomization
* Acute or chronic medical disorder that, in the opinion of the investigator, would impair the ability of the patient to receive protocol treatment
* Previous treatment with other pathogen-reduced blood products
* Females who are pregnant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No