Embolism and Thrombosis Clinical Trial
Official title:
Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs: a Nationwide Pharmacoepidemiological Study
Oral antithrombotic medications (OAM) are used for the prevention and treatment of thrombotic
disorders. Among hemorrhagic complications of OAMs, intracranial hemorrhage (ICH) may have
particularly devastating consequences with high morbidity, disability and mortality rates.
The efficacy and safety profiles of OAMs are generally assessed in randomized controlled
trials (RCT), but included patients are often highly selected and may not be representative
of users in everyday clinical practice in terms of follow-up routines, age, gender, drug
compliance, and polypharmacy. Moreover, it is often unclear whether or not traumatic ICHs are
registered and reported in RCTs. Drifts in indications and treatment criteria may also be
seen in everyday practice and drug discontinuation due to precautionary concerns including
compliance, fall risk and comorbidity may be forgotten. Collectively, these factors may lead
to other and potentially higher traumatic ICH rates in general clinical use than reported in
RCTs.
The incidence rates of traumatic ICH in patients on OAMs in the general population remain
unknown. In this nationwide registry based pharmacoepidemiological study we will investigate
the incidence and case fatality of traumatic ICH in users of OAMs in Norway from 2008 through
2014.
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