Hemorrhagic Disorders Clinical Trial
Official title:
Standardisation of Investigations of Mild Bleeding Disorders
Observational study aimed at evaluating the clinical impact of a standardised diagnostic procedure for the investigation of patients with suspected mild bleeding disorder (MBD).
The working hypothesis of this prospective diagnostic study is that a standardised procedure
in investigating patients with suspected MBD will lead to a better discrimination between
patients with and without MBD and a more precise characterisation of MBD.
The primary objective of this diagnostic study is to evaluate the efficiency of a
standardised procedure of MBD in children and adults referred to their respective outpatient
clinics for bleeding symptoms. The following endpoints will be evaluated:
1. The relative number of precise diagnosis (according to recognised classification of
haemostatic disorders) in each clinical probability category;
2. The number of biological tests performed per patient in each clinical probability
category;
3. The relative number of patients with no specialised investigations in the low risk
group.
The secondary objective is to evaluate the bleeding events during a one-year follow-up.
Follow-up will be performed with a phone call one year after the last consultation of the
patient. The definition of a bleeding event will be any bleeding that promotes any specific
medical attention (consultation, hospitalisation, transfusion, re-intervention in case of
surgery). The detailed clinical history regarding each event will be collected. Bleeding
events will be correlated to the clinical probability assessed at inclusion.
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Observational Model: Cohort, Time Perspective: Prospective
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