Mirasol Evaluation of Reduction in Infections Trial

Launched by JOHNS HOPKINS UNIVERSITY · Nov 8, 2018

Keywords

ClinConnect Summary

The Mirasol Evaluation of Reduction in Infections Trial is a study designed to see how well a special treatment called Mirasol works in preventing infections that can sometimes occur from blood transfusions. The trial compares blood treated with Mirasol to standard blood that has not been treated. It aims to find out if the Mirasol treatment can lower the risk of infections caused by viruses, bacteria, or parasites in patients who need a blood transfusion.

To take part in this trial, participants should be adults or children with low hemoglobin levels (less than 7 g/dL) who need a blood transfusion based on their doctor's advice. They must be willing to come back for follow-up visits at the hospital. However, some people won't qualify, such as those with certain medical conditions or those who have had recent transfusions. If eligible, participants can expect to receive either the treated or standard blood and will have their health monitored at different times during the study to check for any infections. This trial is currently recruiting participants, and everyone’s contribution could help improve blood safety for future transfusions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Willing to participate in study and patient or legally authorized representative has given written informed consent (IC)
• • Hemoglobin \< 7 g/dL or decision to transfusion by clinical team
• • Transfusion necessary based on clinical judgment of attending physician
• • Agree to return to the hospital for the follow-up visits
• Exclusion Criteria:
• • Presence of red cell alloantibodies
• • Incompatible red cell crossmatch
• • Not expected to survive for 10 weeks
• • Expected to require plasma or platelets within next 10 weeks outside of the FWB provided in the trial
• • Blood type AB (due to concern of limited supply)
• • Weight \< 30 kg (due to concern for sufficient blood draws to detect bacteria and other TTIs)
• • HIV-infected
• • Clinical suspicion of sepsis
• • Anti-malarial treatment within 7 days prior to randomization
• • Fever (central body temperature greater than 38.5°C)
• • 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