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A pathogen-reduction system can safely minimize the risk of malaria transmitted via blood transfusion, according to a randomized trial.
The Mirasol pathogen-reduction technology system uses ultraviolet light energy and riboflavin to reduce the pathogen load and inactivate white blood cells in blood products.
In the current study, the system significantly reduced the transmission of malaria-causing Plasmodium parasites in patients receiving whole blood.
“This is the first study to look at the potential of pathogen-reduction technology in a real-world treatment setting and finds that, although the risk of malaria transmission is not completely eliminated, the risk is severely reduced,” said Jean-Pierre Allain, MD, of the University of Cambridge in the UK.
Dr Allain and his colleagues described this research in The Lancet. The work was funded by TerumoBCT Inc., the company developing the Mirasol system.
The trial included 223 adult patients from the Komfo Anokye Teaching Hospital in Kumasi, Ghana, who required a blood transfusion because of severe anemia or hemorrhage and were expected to remain in the hospital for at least 3 consecutive days after the initial transfusion.
The patients were randomized via computer to receive a transfusion with pathogen-reduced whole blood (treated) or whole blood that was prepared and transfused by standard local practice (untreated). Patients, healthcare providers, and data collectors were blinded to the treatment allocation.
The researchers analyzed blood samples for all of the recipients on the day of the transfusion and 1, 3, 7, and 28 days later. By studying the sequences of Plasmodium genes present in the blood, the team was able to tell whether the patients were likely to be carrying the donor parasite after the transfusion.
In all, 214 patients completed the protocol as planned—107 who received treated blood and 107 who received untreated blood.
A total of 65 patients were not previously carrying a Plasmodium parasite but received parasitemic blood. Twenty-eight of these patients received treated blood, and 37 received untreated blood.
The incidence of transfusion-transmitted malaria was significantly lower for the group that received the treated blood. Twenty-two percent of patients (8/37) who received untreated blood later tested positive for the malaria parasite, compared with 4% (1/28) of patients who received treated blood (P=0.039).
The researchers noted that coagulation parameters, platelet counts, and hemostatic status were similar whether patients received treated or untreated blood.
The Mirasol system did not appear to affect the coagulation properties of the blood, and patients who received the treated blood had slightly fewer allergic reactions than those who received the untreated blood (5% vs 8%).
The percentage of patients reporting at least 1 treatment-emergent adverse event (TEAE) was similar between the groups—43% in the treated-blood group and 39% in the untreated-blood group.
Likewise, there were no significant differences between the groups in the incidence of serious TEAEs (12% vs 8%), life-threatening TEAEs (3% for both), hospital admission (5% vs 4%), or death (7% vs 5%). The researchers noted that none of the deaths were related to transfusion or pathogen-reduction technology.
The team said additional studies of this technology are needed in larger populations—in particular, at-risk populations such as young children and pregnant mothers.
Photo by Daniel Gay
A pathogen-reduction system can safely minimize the risk of malaria transmitted via blood transfusion, according to a randomized trial.
The Mirasol pathogen-reduction technology system uses ultraviolet light energy and riboflavin to reduce the pathogen load and inactivate white blood cells in blood products.
In the current study, the system significantly reduced the transmission of malaria-causing Plasmodium parasites in patients receiving whole blood.
“This is the first study to look at the potential of pathogen-reduction technology in a real-world treatment setting and finds that, although the risk of malaria transmission is not completely eliminated, the risk is severely reduced,” said Jean-Pierre Allain, MD, of the University of Cambridge in the UK.
Dr Allain and his colleagues described this research in The Lancet. The work was funded by TerumoBCT Inc., the company developing the Mirasol system.
The trial included 223 adult patients from the Komfo Anokye Teaching Hospital in Kumasi, Ghana, who required a blood transfusion because of severe anemia or hemorrhage and were expected to remain in the hospital for at least 3 consecutive days after the initial transfusion.
The patients were randomized via computer to receive a transfusion with pathogen-reduced whole blood (treated) or whole blood that was prepared and transfused by standard local practice (untreated). Patients, healthcare providers, and data collectors were blinded to the treatment allocation.
The researchers analyzed blood samples for all of the recipients on the day of the transfusion and 1, 3, 7, and 28 days later. By studying the sequences of Plasmodium genes present in the blood, the team was able to tell whether the patients were likely to be carrying the donor parasite after the transfusion.
In all, 214 patients completed the protocol as planned—107 who received treated blood and 107 who received untreated blood.
A total of 65 patients were not previously carrying a Plasmodium parasite but received parasitemic blood. Twenty-eight of these patients received treated blood, and 37 received untreated blood.
The incidence of transfusion-transmitted malaria was significantly lower for the group that received the treated blood. Twenty-two percent of patients (8/37) who received untreated blood later tested positive for the malaria parasite, compared with 4% (1/28) of patients who received treated blood (P=0.039).
The researchers noted that coagulation parameters, platelet counts, and hemostatic status were similar whether patients received treated or untreated blood.
The Mirasol system did not appear to affect the coagulation properties of the blood, and patients who received the treated blood had slightly fewer allergic reactions than those who received the untreated blood (5% vs 8%).
The percentage of patients reporting at least 1 treatment-emergent adverse event (TEAE) was similar between the groups—43% in the treated-blood group and 39% in the untreated-blood group.
Likewise, there were no significant differences between the groups in the incidence of serious TEAEs (12% vs 8%), life-threatening TEAEs (3% for both), hospital admission (5% vs 4%), or death (7% vs 5%). The researchers noted that none of the deaths were related to transfusion or pathogen-reduction technology.
The team said additional studies of this technology are needed in larger populations—in particular, at-risk populations such as young children and pregnant mothers.
Photo by Daniel Gay
A pathogen-reduction system can safely minimize the risk of malaria transmitted via blood transfusion, according to a randomized trial.
The Mirasol pathogen-reduction technology system uses ultraviolet light energy and riboflavin to reduce the pathogen load and inactivate white blood cells in blood products.
In the current study, the system significantly reduced the transmission of malaria-causing Plasmodium parasites in patients receiving whole blood.
“This is the first study to look at the potential of pathogen-reduction technology in a real-world treatment setting and finds that, although the risk of malaria transmission is not completely eliminated, the risk is severely reduced,” said Jean-Pierre Allain, MD, of the University of Cambridge in the UK.
Dr Allain and his colleagues described this research in The Lancet. The work was funded by TerumoBCT Inc., the company developing the Mirasol system.
The trial included 223 adult patients from the Komfo Anokye Teaching Hospital in Kumasi, Ghana, who required a blood transfusion because of severe anemia or hemorrhage and were expected to remain in the hospital for at least 3 consecutive days after the initial transfusion.
The patients were randomized via computer to receive a transfusion with pathogen-reduced whole blood (treated) or whole blood that was prepared and transfused by standard local practice (untreated). Patients, healthcare providers, and data collectors were blinded to the treatment allocation.
The researchers analyzed blood samples for all of the recipients on the day of the transfusion and 1, 3, 7, and 28 days later. By studying the sequences of Plasmodium genes present in the blood, the team was able to tell whether the patients were likely to be carrying the donor parasite after the transfusion.
In all, 214 patients completed the protocol as planned—107 who received treated blood and 107 who received untreated blood.
A total of 65 patients were not previously carrying a Plasmodium parasite but received parasitemic blood. Twenty-eight of these patients received treated blood, and 37 received untreated blood.
The incidence of transfusion-transmitted malaria was significantly lower for the group that received the treated blood. Twenty-two percent of patients (8/37) who received untreated blood later tested positive for the malaria parasite, compared with 4% (1/28) of patients who received treated blood (P=0.039).
The researchers noted that coagulation parameters, platelet counts, and hemostatic status were similar whether patients received treated or untreated blood.
The Mirasol system did not appear to affect the coagulation properties of the blood, and patients who received the treated blood had slightly fewer allergic reactions than those who received the untreated blood (5% vs 8%).
The percentage of patients reporting at least 1 treatment-emergent adverse event (TEAE) was similar between the groups—43% in the treated-blood group and 39% in the untreated-blood group.
Likewise, there were no significant differences between the groups in the incidence of serious TEAEs (12% vs 8%), life-threatening TEAEs (3% for both), hospital admission (5% vs 4%), or death (7% vs 5%). The researchers noted that none of the deaths were related to transfusion or pathogen-reduction technology.
The team said additional studies of this technology are needed in larger populations—in particular, at-risk populations such as young children and pregnant mothers.