Clinical trial NCT02996851: Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs
Official title: Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs: a Nationwide Pharmacoepidemiological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Hemorrhage, Traumatic
Embolism and Thrombosis
Hematoma, Subdural, Intracranial
Keywords: Fibrinolytic Agents
Adverse effects
Norway
Registries
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2016-12-19
Enrollment: 6279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (1) the Norwegian patient registry (NPR), which contains information about all admissions to Norwegian hospitals since 2008 with diagnoses coded according to the 10th revision of the International Classification of Diseases and (2) The Norwegian prescription database (NorPD), which contains information about all prescriptions dispensed in Norway since 2004 including type of drug according to the Anatomical Therapeutic Chemical (ATC) classification system, number of Defined Daily Doses (DDD) as defined by the World Health Organization, date of dispensing, quantity dispensed, and drug strength and formulation. The National Registry provides information to NPR and NorPD on vital status (dead or alive).

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* included in the Norwegian patient registry (NPR) and/or the Norwegian prescription database (NorPD)

Exclusion Criteria:

-

Primary outcomes:
measure: incidence of intracranial hemorrhage requiring hospital admission
timeFrame: at least 12 months following intracranial hemorrhage
Secondary outcomes:
measure: incidence of fatal traumatic intercranial hemorrhage defined as death within 90 days of admission
timeFrame: 90 days
measure: overall survival following traumatic intracranial hemorrhage
timeFrame: 6 years
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian University of Science and Technology
name: Sasha Gulati, md phd
role: PRINCIPAL_INVESTIGATOR
References: