Macopharma and SynteractHCR announce the accomplishment of the European Prospective Non-Interventional study for THERAFLEX MB-Plasma 9/09/2015
MACOPHARMA AND SYNTERACTHCR ANNOUNCE THE ACCOMPLISHMENT OF THE EUROPEAN PROSPECTIVE NON-INTERVENTIONAL STUDY FOR THERAFLEX MB-PLASMA
TOURCOING — SEPTEMBER 9TH, 2015 –
Macopharma today announced the finalization of the European prospective non-interventional study for THERAFLEX MB-Plasma that has started in collaboration with an international CRO (contract research organization) SynteractHCR in November 2013, with the first patient enrolment in Spain.
The aim of this post marketing surveillance study was to collect, during a period of at least one year, adverse events related to MB-treated plasma transfusions in seven key European hospitals in Belgium, UK, Spain and Greece where MB-treated plasma is in routine use.
Last patient enrolment was in March 2015.
In this study the outcome of a total of 19,315 transfused units of MB plasma (3,780 transfusions) was observed. This number is considered adequate to determine the safety of MB plasma. The incidence of serious Adverse Transfusion Reactions (ATRs) was 1 per 19,315 transfused units of MB plasma which is similar to the incidence for untreated fresh frozen plasma reported by the French national authority ANSM. There were no ATRs reported in Greece where 9,241 units of MB plasma were transfused nor in the UK where 434 units were transfused during the observation period.
“We are very happy of the outcome of this study; this observational trial in patients confirms that Methylene Blue plasma is a safe product” Macopharma Clinical Research Manager Dr. Ignacio Alvarez, said. “We are also very satisfied about the great collaboration we had with SynteractHCR.”