AIMS: African Investigation of Mirasol System for Whole Blood

Not Applicable

• Conditions: Haematological Disorders; Malaria

• Registration Number: PACTR201406000777310
• Lead Sponsor: Terumo BCT Europe N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-27
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Age equal to or more than 18 years.
Blood group O+.
Hospitalized for at least 3 consecutive days after initial study transfusion.
Require no more than 2 units of whole blood in the 3 days following randomization.
Agree to return to the hospital for follow-up visits.
Women of child bearing potential must have negative pregnancy test within 72 hours before randomization and must agree to practice a 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.
Anti-malarial treatment within 7 days prior to randomization.
Fever greater than 38.5°C.
Massive bleeding expected to require more than 2 whole blood units within 3 days from randomization.
Transfusion 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 pregant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified