Clinical trial NCT02329899: Standardisation of Investigations of Mild Bleeding Disorders
Official title: Standardisation of Investigations of Mild Bleeding Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhagic Disorders
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 208
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (children or adults) referred to a tertiary care center (haemostasis unit) for investigation of mild bleeding symptoms (with suspicion of mild bleeding disorder)

Brief 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.

Eligibility criteria: Inclusion Criteria:

* All patients aged more than two years-old referred by their physician (gynaecologist, paediatrician, general practitioner, surgeon, etc.) for investigations of a possible bleeding tendency will be included in this study. This prospective study will include consecutive patients attending the four outpatient clinics (Division of Angiology and Haemostasis and Paediatric Onco-Haematology Unit, University Hospitals of Geneva).

Exclusion Criteria:

* Pregnant women will be excluded because of modifications of the known modifications of the haemostasis system during pregnancy. Adult patients without discernment capacity will be excluded.

Primary outcomes:
measure: Relative number of precise diagnosis
timeFrame: after the completion of the standardized diagnostic procedure (on average 6 weeks after enrollment)
measure: Number of biological tests performed per patient
timeFrame: after the completion of the standardized diagnostic procedure (on average 6 weeks after enrollment)
measure: Relative number of patients with no specialised investigations in the low risk group
timeFrame: after the completion of the standardized diagnostic procedure (on average 1 week after enrollment in this low risk group)
Secondary outcomes:
measure: Evaluation of bleeding events
timeFrame: After one year follow-up
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Haemostasis unit, University Hospitals of Geneva
Study officials:
affiliation: Haemostasis unit, University Hospitals of Geneva, Switerland
name: Boehlen Francoise, MD
role: PRINCIPAL_INVESTIGATOR
References: