Haematological Disorders Malaria
Conditions
Interventions
Mirasol-treated whole blood transfusion
untreated whole blood transfusion
Sponsors
Terumo BCT Europe N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of transfusion-transmitted malaria | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacterial contamination of whole blood products;Transmission rates in subpopulation of prior non-parasitemic subjects receiving parasitemic products;Transfusion reactions and treatment-emergent adverse events.;Hematological, biochemistry and coagulation parameters in whole blood products and patients | — |
Countries
Ghana
Contacts
Public ContactLiesbeth Deberdt
Clinical Project Leader/Terumo BCT
Outcome results
None listed