Risk of intracranial hemorrhage in users of oral antithrombotic drugs: Study protocol for a nationwide study [version 1; referees: 2 approved]
Sasha Gulati,
Ole Solheim,
Sven M. Carlsen,
Lise R. Øie,
Heidi Jensberg,
Agnete M. Gulati,
Charalampis Giannadakis,
Asgeir S. Jakola,
Øyvind Salvesen
Affiliations
Sasha Gulati
Norwegian Centre of Competence in Deep Brain Stimulation for Movement Disorders, St. Olavs University Hospita, Trondheim, 7030, Norway
Ole Solheim
National Advisory Unit on Ultrasound and Image-Guided Therapy, St. Olavs University Hospital, Trondheim, 7030, Norway
Sven M. Carlsen
Unit for Applied Clinical Research, Department of Cancer Research and Molecular Medicine,, Norwegian University of Science and Technology (NTNU), Trondheim, 7491, Norway
Lise R. Øie
Department of Neurology, St. Olavs University Hospital, Trondheim, 7030, Norway
Department of Rheumatology, St. Olavs University Hospital, Trondheim, 7030, Norway
Charalampis Giannadakis
Department of Neuroscience, Norwegian University of Science and Technology (NTNU), Trondheim, 7491, Norway
Asgeir S. Jakola
Institute of Neuroscience and Physiology, University of Gothenburg, Sahlgrenska Academy, Gothenburg, 413 90, Sweden
Øyvind Salvesen
Unit for Applied Clinical Research, Department of Cancer Research and Molecular Medicine,, Norwegian University of Science and Technology (NTNU), Trondheim, 7491, Norway
Background A wide range of antithrombotic medications can be used in the prevention and treatment of thrombosis. Among hemorrhagic complications of antithrombotic drugs, intracranial hemorrhage may have particularly devastating consequences with high morbidity, disability and mortality rates. The incidence and risks of intracranial hemorrhage in patients on antithrombotic treatments from regular clinical practice outside clinical trials remain largely unknown. It is not known if results from clinical trials can be extrapolated to everyday clinical practice. We will conduct a nationwide study to investigate the risks and incidence rates of intracranial hemorrhage in users oral antithrombotic drugs in Norway from 2008 through 2014. Methods and design The aim of this nationwide study is to investigate the incidence rates of intracranial hemorrhage requiring hospitalization in users of oral antithrombotic drugs. The study will be conducted within the approximately 4.7 million inhabitants of Norway from January 1st, 2008, to December 31st, 2014. Treatment and outcome data are obtained from the Norwegian patient registry and the Norwegian prescription database. Trial registration number Clinicaltrials.gov (NCT02481011)
