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|SeveN A in Nonhemophilia Bleeding in Pediatrics|
A web-based Clinical registry for monitoring and evaluation of the treatment of severe and/or life threatening bleeding using rFVIIa in children without haemophilia.
During the 50th ISTH SSC meeting in Venice 2004, the need for evaluation of rFVIIa in treatment of bleeding in nonhemophilic children was discussed. This was the impulse for designing the software that registers individual cases, where rFVIIa has been administered to control bleeding/massive haemorrhage in children. It is based on a stable Oracle 9i platform with web-based interface for data entry. The whole project is compatible with legal regulations of European Union and United States of America including personal data protection issues. The project was developed in cooperation between Perinatal/Pediatric Hemostasis Subcommittee SSC, ISTH and Masaryk University in Brno, Czech Republic and it is endorsed by both organizations. Masaryk University will sponsor the project for its first year. The registry will be launched during XXth Congress of the International Society on Thrombosis and Haemostasis in Sydney, Australia.
This registry will be used to capture information regarding the use of rFVIIa in nonhemophilia bleeding in children. Please note that this is a voluntary registry, and we depend on the altruism and goodness of the investigators to enter this information. A consent/assent form is attached which may be used for those institutions that need IRB/ethics committee approval. The chair of the Perinatal/Pediatric hemostasis committee of the SSC, (currently Dr. Massicotte), Dr. Jan Blatny and Dr. Prasad Mathew will oversee the running of this registry. If you have any questions, please do not hesitate to call upon us.
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