Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs

Embolism and Thrombosis Clinical Trial

Official title:

Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs: a Nationwide Pharmacoepidemiological Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996851
• Other study ID #: 2014/958
• Status: Completed
• Phase: N/A
• First received: December 15, 2016
• Last updated: October 16, 2017
• Start date: January 2007
• Est. completion date: December 31, 2014

Study information

• Verified date: October 2017
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6279
• Est. completion date: December 31, 2014
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Embolism
• Embolism and Thrombosis
• Hematoma
• Hematoma, Subdural, Intracranial
• Hemorrhage
• Intracranial Hemorrhage, Traumatic
• Intracranial Hemorrhages
• Thrombosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of intracranial hemorrhage requiring hospital admission	Age- and gender-adjusted comparisons of annual incidence rates will be carried out	at least 12 months following intracranial hemorrhage
Secondary	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.	90 days
Secondary	overall survival following traumatic intracranial hemorrhage		6 years