Standardisation of Investigations of Mild Bleeding Disorders

Hemorrhagic Disorders Clinical Trial

— MBD  

Official title:

Standardisation of Investigations of Mild Bleeding Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329899
• Other study ID #: 10-246
• Status: Completed
• Phase: N/A
• First received: December 22, 2014
• Last updated: November 3, 2016
• Start date: July 2012
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Disease
• Hemorrhagic Disorders
• Hemostatic Disorders

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Haemostasis unit, University Hospitals of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Number of biological tests performed per patient		after the completion of the standardized diagnostic procedure (on average 6 weeks after enrollment)	No
Primary	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)	No
Secondary	Evaluation of bleeding events	Phone call	After one year follow-up	No