RISK OF AGRANULOCYTOSIS ASSOCIATED WITH THE USE OF DRUGS

Study identification

• EU PAS number:
  EUPAS2548
• Study ID:
  10857
• Official title and acronym:
  RISK OF AGRANULOCYTOSIS ASSOCIATED WITH THE USE OF DRUGS
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  The 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.
• Study status:
  Planned

Research institutions and networks

Institutions

Fundació Institut Català de Farmacologia (FICF)

Spain

Bellvitge University Hospital

University Hospital Vall d’Hebron (HUVH)

Spain

Clinical Pharmacology Department, Area del Medicament, Hospital Clínic de Barcelona

Spain

Parc de Salut Mar Barcelona (PSMAR)

Spain

Consorci Corporació Sanitària Parc Taulí

Spain

Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau – IIB Sant Pau

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

Networks

EUDRAGENE

France

Italy

Netherlands

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 01/01/1980

Study start date

Planned: 01/01/1980

Data analysis start date

Planned: 01/01/1986

Date of final study report

Planned: 31/07/2015

Sources of funding

Other

More details on funding

Agencia Española del Medicamento

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable