Intracranial Hemorrhage, TraumaticNCT02996851
Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs
An observational study of Intracranial Hemorrhage, Traumatic and Embolism and Thrombosis, run by St. Olavs Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hemorrhage, Traumatic, Embolism and Thrombosis, Hematoma, Subdural, Intracranial
- How many people
- 6,279 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to 31 Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- included in the Norwegian patient registry (NPR) and/or the Norwegian prescription database (NorPD)
Who cannot join
- -
About this study
Official title: 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.
- Conditions
- Intracranial Hemorrhage, Traumatic, Embolism and Thrombosis, Hematoma, Subdural, Intracranial
- Keywords
- Fibrinolytic Agents, Adverse effects, Norway, Registries
- Medical subject headings
- Intracranial Hemorrhage, Traumatic, Embolism and Thrombosis, Hematoma, Subdural, Intracranial
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of intracranial hemorrhage requiring hospital admission
Age- and gender-adjusted comparisons of annual incidence rates will be carried out
Measured: at least 12 months following intracranial hemorrhage
Secondary outcomes (2)
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.
Measured: 90 days
overall survival following traumatic intracranial hemorrhage
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startJan 2007
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Hemorrhage, TraumaticStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 6,279 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Sasha Gulati, md phd, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996851
- Sponsor's protocol ID
- 2014/958
- Status last verified
- Oct 2017
- First submitted
- 15 Dec 2016
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs: a Nationwide Pharmacoepidemiological Study
- ClinicalTrials.gov ID
- NCT02996851
- Acronym / sponsor ID
- 2014/958
- Conditions
- Intracranial Hemorrhage, Traumatic, Embolism and Thrombosis, Hematoma, Subdural, Intracranial
- Keywords
- Fibrinolytic Agents, Adverse effects, Norway, Registries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,279 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Jan 2007 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- included in the Norwegian patient registry (NPR) and/or the Norwegian prescription database (NorPD)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
incidence of fatal traumatic intercranial hemorrhage defined as death within 90 days of admission
Time frame: 90 days
overall survival following traumatic intracranial hemorrhage
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sasha Gulati, md phd principal investigator
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hemorrhage, Traumatic and Embolism and Thrombosis, run by St. Olavs Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of intracranial hemorrhage requiring hospital admission (time frame: at least 12 months following intracranial hemorrhage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.