Standardisation of Investigations of Mild Bleeding Disorders

Completed

• Conditions: Hemorrhagic Disorders
• Interventions: Other: Second step of investigations

• 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

Arm && Interventions

Group	Intervention	Description
MBD unlikely	Second step of investigations	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.
Possible MBD	Second step of investigations	Defined by: * a bleeding score \>= 4 in adults; * a bleeding score \>= 2 in children (for girls, up to menses); * a past medical history that include menorrhagia, haemorrhage from the umbilical stump, bleeding at circumcision, cephalhematoma at birth, hematuria, whatever the bleeding score is; * a past medical history suggestive of a MBD with no haemostatic challenge and a low bleeding score. In this group, the second step of investigations will be performed.

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