Status: Planned First registered on: 11/04/2012
Last updated on: 03/09/2015
1. Study identification
EU PAS Register NumberEUPAS2548
Official titleRISK OF AGRANULOCYTOSIS ASSOCIATED WITH THE USE OF DRUGS
Study title acronymNone.
Study typeObservational study
Brief description of the studyThe objective of this study is to estimate the risk of agranulocytosis associated with the use of drugs. Agranulocytosis is a serious condition, with an estimated incidence of 1.6:1 million to 7.0:1 million inhabitants per year.1,2 Case fatality is around 10%, but this may depend to a large extent on the availability of prompt antibiotic treatment. Almost all classes of medicines have been implicated in agranulocytosis. Since 1980, a case-control surveillance study of Agranulocytosis has been carried out in the metropolitan area of Barcelona. With the aim of identifying all cases of agranulocytosis occurring in the study population. Our centre maintains regular contact with a designated hematologist of all hospitals in the area. Potential cases are patients with a granulocyte count of <500/mm3, or a total white series count of <3,000/mm3 in two consecutive counts, with a hemoglobin level of 10 g/dl and a platelet count of 100,000/mm3.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
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 belongsFICF
Department/Research group
Organisation/affiliationFundació Institut Català de Farmacologia
Website/Homepagewww.icf.uab.cat
Details of (Primary) lead investigator
Title Professor
Last name Laporte
First name Joan-Ramon
Is this study being carried out with the collaboration of a research network?
Yes

EUDRAGENE
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?16

Hospital Clinic Barcelona
Hospital Universitari Vall d’Hebron, Barcelona
Hospital de la Santa Creu i Sant Pau, Barcelona
Hospital del Mar, Barcelona
Hospital de Barcelona, Barcelona
Fundació Hospital/Asil de Granollers, Granollers
Hospital de Mataró, Mataró
Hospital Universitari Germans Trias i Pujol, Badalona
Hospital de Terrassa, Terrassa
Hospital Universitari de Bellvitge, Bellvitge
Corporació Sanitària i Universitària Parc Taulí, Sabadell
Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/01/1980
Start date of data collection01/01/1980
Start date of data analysis01/01/1986
Date of interim report, if expected
Date of final study report31/07/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyAgencia Española del Medicamento100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Ibáñez
First name Luisa
Address line 1Vall d’Hebron 119-129
Address line 2Antiga Escola Infermeria 
Address line 3Servei de Farmacologia Clínica 
CityBarcelona 
Postcode08035 
CountrySpain
Phone number (incl. country code)34934894105 
Alternative phone number 
Fax number (incl. country code) 
Email address li@icf.uab.cat
Public Enquiries
Title Dr 
Last name Ibáñez 
First name Luisa 
Address line 1Vall d’Hebron 119-129 
Address line 2Antiga Escola Infermeria 
Address line 3Servei de Farmacologia Clínica 
CityBarcelona 
Postcode08035 
CountrySpain 
Phone number (incl. country code)34934894105 
Alternative phone number 
Fax number (incl. country code) 
Email address li@icf.uab.cat 
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