Standardisation of Investigations of Mild Bleeding Disorders

Completed

• Conditions: Hemorrhagic Disorders

• Registration Number: NCT02329899
• Lead Sponsor: University Hospital, Geneva

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2014-12-22
• Study First Submitted QC: 2014-12-31
• Study First Posted: 2015-01-01
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
Relative number of precise diagnosis	after the completion of the standardized diagnostic procedure (on average 6 weeks after enrollment)	Diagnosis are going to be evaluated according to recognized classification of haemostatic disorders

Secondary Outcome Measures

Name	Time	Method
Evaluation of bleeding events	After one year follow-up	Phone call

Trial Locations

Locations (1)

Haemostasis unit, University Hospitals of Geneva; 🇨🇭 Geneva, Switzerland