NCT02329899

Standardisation of Investigations of Mild Bleeding Disorders

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 208 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

Observational study aimed at evaluating the clinical impact of a standardised diagnostic procedure for the investigation of patients with suspected mild bleeding disorder (MBD).

Detailed description

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.

Conditions

• Hemorrhagic Disorders

Interventions

Type	Name	Description
OTHER	Second step of investigations	Second step according to results of the first step: * exploration of coagulation factors; * factor XIII and fibrinolysis investigations; * investigation of platelet function; * investigation of thrombocytopenia.

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-01-01
• Last updated: 2016-11-04

Locations

1 site across 1 country: Switzerland