Risk of intracranial hemorrhage in users of oral antithrombotic drugs: Study protocol for a nationwide study

Sasha Gulati; Ole Solheim; Sven M Carlsen; Lise R Øie; Heidi Jensberg; Agnete M Gulati; Charalampis Giannadakis; Asgeir S Jakola; Øyvind Salvesen

doi:10.12688/f1000research.7633.1

Risk of intracranial hemorrhage in users of oral antithrombotic drugs: Study protocol for a nationwide study

F1000Res. 2015 Dec 30:4:1519. doi: 10.12688/f1000research.7633.1. eCollection 2015.

Authors

Sasha Gulati¹, Ole Solheim², Sven M Carlsen³, Lise R Øie⁴, Heidi Jensberg⁵, Agnete M Gulati⁶, Charalampis Giannadakis⁷, Asgeir S Jakola⁸, Øyvind Salvesen⁹

Affiliations

¹ Department of Neurosurgery, St. Olavs University Hospital, Trondheim, 7030, Norway; Department of Neuroscience, Norwegian University of Science and Technology (NTNU), Trondheim, 7491, Norway; National Advisory Unit on Spinal Surgery, St. Olavs University Hospital, Trondheim, 7030, Norway; Norwegian Centre of Competence in Deep Brain Stimulation for Movement Disorders, St. Olavs University Hospita, Trondheim, 7030, Norway.
² Department of Neurosurgery, St. Olavs University Hospital, Trondheim, 7030, Norway; Department of Neuroscience, Norwegian University of Science and Technology (NTNU), Trondheim, 7491, Norway; National Advisory Unit on Ultrasound and Image-Guided Therapy, St. Olavs University Hospital, Trondheim, 7030, Norway.
³ Department of Endocrinology, St. Olavs University Hospital, Trondheim, 7030, Norway; Unit for Applied Clinical Research, Department of Cancer Research and Molecular Medicine,, Norwegian University of Science and Technology (NTNU), Trondheim, 7491, Norway.
⁴ Department of Neuroscience, Norwegian University of Science and Technology (NTNU), Trondheim, 7491, Norway; Department of Neurology, St. Olavs University Hospital, Trondheim, 7030, Norway.
⁵ Norwegian Patient Registry, Trondheim, 1601, Norway.
⁶ Department of Neuroscience, Norwegian University of Science and Technology (NTNU), Trondheim, 7491, Norway; Department of Rheumatology, St. Olavs University Hospital, Trondheim, 7030, Norway.
⁷ Department of Neuroscience, Norwegian University of Science and Technology (NTNU), Trondheim, 7491, Norway.
⁸ Department of Neurosurgery, St. Olavs University Hospital, Trondheim, 7030, Norway; Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, 413 45, Sweden; Institute of Neuroscience and Physiology, University of Gothenburg, Sahlgrenska Academy, Gothenburg, 413 90, Sweden.
⁹ Unit for Applied Clinical Research, Department of Cancer Research and Molecular Medicine,, Norwegian University of Science and Technology (NTNU), Trondheim, 7491, Norway.

Abstract

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 1 (st), 2008, to December 31 (st), 2014. Treatment and outcome data are obtained from the Norwegian patient registry and the Norwegian prescription database. Trial registration number Clinicaltrials.gov (NCT02481011).

Keywords: Drug-Related Side Effects and Adverse Reactions; Hematoma; Intracranial; Stroke; Subdural.

Associated data

ClinicalTrials.gov/NCT02481011

Grants and funding

This study is funded by a grant from the Liaison Committee between the Central Norway Regional Health Authority and the Norwegian University of Science and Technology. The funders have no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.