HemMa Study

HemMa is a prospective cross-sectional observational study that aims to identify hematological markers in patients with sickle cell disease. The study is a collaboration between the Biologics Research Center of CSL Behring at SITEM and the Department of Hematology of the University Hospital (Inselspital) Bern. CTU Bern is involved in designing, implementing, conducting, and analyzing the study.

The HemMa study investigates a very rare and serious illness named “sickle cell disease”. The disease causes red blood cells to break down and can affect nearly every organ in the human body. Patients suffer from a poor quality of life and a reduced life expectancy.

The study collects blood and urine samples in patients with sickle cell disease and a matched control group. The primary aim is to identify potentially novel biomarkers to more precisely characterize the pathophysiological mechanisms involved in the disease complications.

Services

Document Development

CTU Bern helped to plan the study and to develop important study-specific documents such as the study protocol and patient information.

Regulatory Support

CTU Bern is responsible for submitting the study to the ethics committees in order to obtain approval.

Project Management

CTU Bern coordinates the study and serves as the main contact person for the involved study personnel.

Data Management

CTU Bern set up the study in the secuTrial database and maintains the database during the study.

Statistics

CTU Bern is responsible for statistical planning and analyses.

On-site Monitoring

CTU Bern initiated the study in collaboration with the sponsor. During the conduct of the study, two monitoring visits are planned at the recruiting site.