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

NCT02118428 | Completed Results DMC

• 1 other identifier: CTS-5031
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malaria

Keywords

whole blood; transfusion; Plasmodium; Malaria; Pathogen Reduction Technology; Whole blood transfusion

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Incidence of Transfusion-transmitted Malaria

  Percentage of Participants who contracted transfusion-transmitted malaria (TTM)

  Up to 28 (+4) days after the initial whole blood transfusion (measured within 24 hours prior to each transfusion and at 24 (± 4) hours, 2 days, 3 days, 7 (+1) days, and 28 (+4) days after the initial whole blood transfusion)

Secondary Outcomes (16)

• Bacterial Contamination of Fresh Whole Blood (FWB) Products

  immediately post-blood product collection & within 7 days before transfusion, post-Mirasol treatment (within 24 hours post-blood product collection) & within 7 days before transfusion

• Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit

  Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)

• Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin

  Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)

• Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count

  Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)

• Hematology Parameter in Fresh Whole Blood Products - Platelet Count

  Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)

Study Arms (2)

Mirasol

EXPERIMENTAL

Transfusions with Mirasol-treated whole blood

Device: Mirasol-treated Whole Blood

Control

ACTIVE COMPARATOR

Transfusions with untreated whole blood

Biological: Untreated Whole Blood

Interventions

Mirasol-treated Whole Blood DEVICE

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

Mirasol

Untreated Whole Blood BIOLOGICAL

Transfusion with untreated fresh Whole Blood

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Terumo BCTbio: lead

Study Sites (1)

Komfo Anokye Teaching Hospital

Kumasi, Ghana

Location

Related Publications (1)

• Allain JP, Owusu-Ofori AK, Assennato SM, Marschner S, Goodrich RP, Owusu-Ofori S. Effect of Plasmodium inactivation in whole blood on the incidence of blood transfusion-transmitted malaria in endemic regions: the African Investigation of the Mirasol System (AIMS) randomised controlled trial. Lancet. 2016 Apr 23;387(10029):1753-61. doi: 10.1016/S0140-6736(16)00581-X.

  PMID: 27116282 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Limitations and Caveats

Necessary powering for the overall number of transfusions even though a smaller subgroup of non-parasitaemic patients receiving parasitaemic blood was the a-priori defined population to be assessed. Sufficient power was nevertheless maintained.

Results Point of Contact

• Title: Ray Goodrich, PhD
• Organization: Terumo BCT Biotechnologies, LLC

ray.goodrich@terumobct.com

(303) 231-4832

Study Officials

• Shirley Owusu-Ofori, MD

  Komfo Anokye Teaching Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: April 21, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 10, 2019
• Results First Posted: May 10, 2019

Record last verified: 2019-02

Locations

GH (1)