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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Possible MBD | Defined by:
In this group, the second step of investigations will be performed. |
| |
| MBD unlikely | Patients without criteria for possible MBD as listed above. In this group, no further investigation will be performed if the first step is normal. The second step of investigations will be performed only in case of significant abnormalities in the first step of investigation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Second step of investigations | Other | Second step according to results of the first step:
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative number of precise diagnosis | Diagnosis are going to be evaluated according to recognized classification of haemostatic disorders | after the completion of the standardized diagnostic procedure (on average 6 weeks after enrollment) |
| Number of biological tests performed per patient | after the completion of the standardized diagnostic procedure (on average 6 weeks after enrollment) | |
| Relative number of patients with no specialised investigations in the low risk group | after the completion of the standardized diagnostic procedure (on average 1 week after enrollment in this low risk group) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of bleeding events | Phone call | After one year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Patients (children or adults) referred to a tertiary care center (haemostasis unit) for investigation of mild bleeding symptoms (with suspicion of mild bleeding disorder)
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| Name | Affiliation | Role |
|---|---|---|
| Boehlen Francoise, MD | Haemostasis unit, University Hospitals of Geneva, Switerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haemostasis unit, University Hospitals of Geneva | Geneva | 1205 | Switzerland |
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| ID | Term |
|---|---|
| D006474 | Hemorrhagic Disorders |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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2 aliquots of plasma from 2x 6 ml EDTA blood 2 aliquots of plasma from 2 x 2.7 ml citrate blood 2 aliquots of plasma from 1 x 4 ml heparin blood Storage at -80°C