Status: Finalised First registered on: 14/02/2019
Last updated on: 14/02/2019
1. Study identification
EU PAS Register NumberEUPAS28126
Official titleNon-traumatic Haemorrhagic Adverse Events: A Cross-sectional Study in Emergency Departments
Study title acronymHARER
Study typeObservational study
Brief description of the studyBleeding is a common clinical emergency that requires urgent medical attention. There is a general clinical interest in haemorrhages, which is increasing due to the recent introduction of new oral anti-coagulant drugs. Data about the incidence of bleeding in Emergency Room (ER) are lacking in literature, even if several studies report emergency admissions for haemorrhages associated with specific drugs or apparatuses. The retrospective observational study Haemorrhagic Adverse Reactions in Emergency Room (HARER) was designed in order to estimate the incidence of bleeding events and the incidence of suspected haemorrhagic adverse drug reactions as causes of Emergency Room visits. HARER takes into consideration the computerized medical records from two Emergency Departments of the University Hospital in Verona (Italy) from 2015 to 2016 over a twelve month period. According to a validated list available in literature , patients aged ≥ 18 years with an International Classification of Diseases, 9th Revision (ICD-9) diagnosis code at admission related to haemorrhage, but not caused by traumatic events, were included in the study. Unique identification code of the patient with a bleeding episode (as anonymization procedure), date of birth, gender, ICD-9 code, diagnosis at admission, complete patient’s medical history and outcome were recorded. Data were extrapolated from the First Aid database, which contains evaluation at admission, medical history, concomitant pharmacological treatment, descriptive discharge diagnosis, its corresponding ICD-9 CM code and outcome.Haemorrhages were classified into 5 groups: cerebral haemorrhage, gastrointestinal bleeding, epistaxis, haematuria and other haemorrhages.Drugs known to beassociated with haemorrhagic events were grouped into six categories:anticoagulants, antiplatelet drugs, heparins, SSRIs and NSAIDs, and we considered suspected haemorrhagic ADEs in all patient records reporting at least one of these drugs.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsPharmacol UNIVR
Department/Research groupPharmacology Unit - Veneto Pharmacovigilance Centre
Organisation/affiliationUniversity Hospital Verona
Website/Homepagehttp://www.ddsp.univr.it/?ent=sezione&id=27
Details of (Primary) lead investigator
Title Professor
Last name Roberto
First name Leone
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed09/12/201509/12/2015
Start date of data collection01/02/201601/02/2016
Start date of data analysis01/08/2016
Date of interim report, if expected
Date of final study report01/08/201706/04/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Roberto
First name Leone
Address line 1Pharmacology Unit
Address line 2Policlinico GB Rossi 
Address line 3P.le L.A. Scuro 10 
CityVerona 
Postcode37134 
CountryItaly
Phone number (incl. country code)390458124706 
Alternative phone number390458027612 
Fax number (incl. country code)390458124876 
Email address roberto.leone@univr.it
Public Enquiries
Title Professor 
Last name Roberto 
First name Leone 
Address line 1Pharmacology Unit 
Address line 2Policlinico GB Rossi 
Address line 3P.le L.A. Scuro 10 
CityVerona 
Postcode37134 
CountryItaly 
Phone number (incl. country code)390458124706 
Alternative phone number390458027612 
Fax number (incl. country code)390458124876 
Email address roberto.leone@univr.it 
Top