An observational study in Intracranial Hemorrhage, Traumatic, Embolism and Thrombosis and Hematoma, Subdural, Intracranial, sponsored by St. Olavs Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-17.
Sponsored by St. Olavs Hospital · Observational
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.
61 studies on the registry are indexed under Embolism and Thrombosis; 14 are open to participants now.
This study's enrollment of 6,279 is above the median of 280 across 27 observational studies indexed under Embolism and Thrombosis.
Browse Embolism and Thrombosis studies →St. Olavs Hospital is the lead sponsor of 171 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
(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).
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Exclusion Criteria:
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incidence of intracranial hemorrhage requiring hospital admission
Age- and gender-adjusted comparisons of annual incidence rates will be carried out
Time frame: at least 12 months following intracranial hemorrhage
incidence of fatal traumatic intercranial hemorrhage defined as death within 90 days of admission
Age- and gender-adjusted comparisons of annual incidence rates will be carried out.
Time frame: 90 days
overall survival following traumatic intracranial hemorrhage
Time frame: 6 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2007 to primary completion in Dec 2014, 95 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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