Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs
|ClinicalTrials.gov Identifier: NCT02996851|
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : October 17, 2017
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.
|Condition or disease|
|Intracranial Hemorrhage, Traumatic Embolism and Thrombosis Hematoma, Subdural, Intracranial|
|Study Type :||Observational|
|Actual Enrollment :||6279 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs: a Nationwide Pharmacoepidemiological Study|
|Actual Study Start Date :||January 2007|
|Primary Completion Date :||December 31, 2014|
|Study Completion Date :||December 31, 2014|
- incidence of intracranial hemorrhage requiring hospital admission [ Time Frame: at least 12 months following intracranial hemorrhage ]Age- and gender-adjusted comparisons of annual incidence rates will be carried out
- incidence of fatal traumatic intercranial hemorrhage defined as death within 90 days of admission [ Time Frame: 90 days ]Age- and gender-adjusted comparisons of annual incidence rates will be carried out.
- overall survival following traumatic intracranial hemorrhage [ Time Frame: 6 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996851
|Principal Investigator:||Sasha Gulati, md phd||Norwegian University of Science and Technology|