Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs

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.

Study Overview

• Status: Completed
• Conditions: Embolism and Thrombosis; Intracranial Hemorrhage, Traumatic; Hematoma, Subdural, Intracranial

• Study Type: Observational
• Enrollment (Actual): 6279

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
overall survival following traumatic intracranial hemorrhage		6 years

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology
• Investigators: Principal Investigator: Sasha Gulati, md phd, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2007
• Primary Completion (Actual): December 31, 2014
• Study Completion (Actual): December 31, 2014

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 15, 2016
• First Posted (Estimate): December 19, 2016

Study Record Updates

• Last Update Posted (Actual): October 17, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Registries; Norway; Adverse effects; Fibrinolytic Agents
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Embolism; Hemorrhage; Thrombosis; Intracranial Hemorrhages; Hematoma; Hematoma, Subdural; Embolism and Thrombosis; Intracranial Hemorrhage, Traumatic; Hematoma, Subdural, Intracranial
• Other Study ID Numbers: 2014/958

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO