NCT02481011

Brief Summary

The true incidence and risks of intracranial hemorrhage (ICH) in patients on various antithrombotic treatments remain unknown. Here a nationwide study is conducted to investigate the risk for and incidence rates of ICH in users and non-users of various oral antithrombotic drugs in Norway between 2008 through 2014. Hopefully, this study will contribute to a more responsible prescription pattern of antithrombotic medications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22,111

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

June 22, 2015

Last Update Submit

August 24, 2018

Conditions

Intracranial HemorrhagesStroke

Keywords

Fibrinolytic agentsAdverse effectsRegistriesIncidenceRisk assessment

Outcome Measures

Primary Outcomes (1)

  • incidence rate of intracranial hemorrhage (ICH) requiring hospitalization

    We will determine the incidence rates of ICH in users and non-users of oral antithrombotic treatment by linking data from Norwegian Patient Register (NPR) and the Norwegian prescription database.

    6 years

Secondary Outcomes (2)

  • overall survival following ICH

    6 years

  • proportion of ICH patients undergoing neurosurgical procedures

    6 years

Study Arms (2)

users

patients on antithrombotic drugs admitted to a Norwegian hospital for intracranial hemorrhage (ICH)

Drug: antithrombotic drugs

non-users

patients not on antithrombotic drugs admitted to a Norwegian hospital for intracranial hemorrhage (ICH)

Interventions

antithrombotic drugsDRUG
users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with intracranial hemorrhage admitted to hospitals in Norway 2008-2014

You may qualify if:

  • hospitalization due to intracranial hemorrhage (ICH)
  • residential address in Norway

You may not qualify if:

  • Traumatic (high-energy) intracranial injury
  • Parenteral antithrombotic treatment
  • ICH related to tumor or vascular malformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (2)

  • Gulati S, Solheim O, Carlsen SM, Oie LR, Jensberg H, Gulati AM, Giannadakis C, Jakola AS, Salvesen O. Risk of intracranial hemorrhage in users of oral antithrombotic drugs: Study protocol for a nationwide study. F1000Res. 2015 Dec 30;4:1519. doi: 10.12688/f1000research.7633.1. eCollection 2015.

    PMID: 26918124BACKGROUND

  • Gulati S, Solheim O, Carlsen SM, Oie LR, Jensberg H, Gulati AM, Madsbu MA, Giannadakis C, Jakola AS, Salvesen O. Risk of intracranial hemorrhage (RICH) in users of oral antithrombotic drugs: Nationwide pharmacoepidemiological study. PLoS One. 2018 Aug 23;13(8):e0202575. doi: 10.1371/journal.pone.0202575. eCollection 2018.

    PMID: 30138389RESULT

MeSH Terms

Conditions

Intracranial HemorrhagesStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sasha Gulati, md phd

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2015

First Posted

June 25, 2015

Study Start

May 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

August 28, 2018

Record last verified: 2018-08

Locations

NO(1)