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Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs

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ClinicalTrials.gov Identifier: NCT02996851
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

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.


Condition or disease
Intracranial Hemorrhage, Traumatic Embolism and Thrombosis Hematoma, Subdural, Intracranial

Study Type : Observational
Actual Enrollment : 6279 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs: a Nationwide Pharmacoepidemiological Study
Actual Study Start Date : January 2007
Actual Primary Completion Date : December 31, 2014
Actual Study Completion Date : December 31, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. overall survival following traumatic intracranial hemorrhage [ Time Frame: 6 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996851


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

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT02996851     History of Changes
Other Study ID Numbers: 2014/958
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by St. Olavs Hospital:
Fibrinolytic Agents
Adverse effects
Norway
Registries

Additional relevant MeSH terms:
Embolism and Thrombosis
Hemorrhage
Thrombosis
Embolism
Hematoma
Intracranial Hemorrhages
Intracranial Hemorrhage, Traumatic
Hematoma, Subdural
Hematoma, Subdural, Intracranial
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries