Standardisation of Investigations of Mild Bleeding Disorders

University Hospital, Geneva208 enrolled

Overview

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: 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 Type

OBSERVATIONAL

Enrollment

208

Conditions

Hemorrhagic Disorders

Interventions

Second step of investigationsOTHER

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.

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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.

Locations (1)

Haemostasis unit, University Hospitals of Geneva

Geneva, Switzerland

Outcomes

Primary Outcomes

Relative number of precise diagnosis

Diagnosis are going to be evaluated according to recognized classification of haemostatic disorders

Time frame: after the completion of the standardized diagnostic procedure (on average 6 weeks after enrollment)

Number of biological tests performed per patient

Time frame: 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

Time frame: after the completion of the standardized diagnostic procedure (on average 1 week after enrollment in this low risk group)

Secondary Outcomes

Evaluation of bleeding events

Phone call

Time frame: After one year follow-up

Data from ClinicalTrials.gov

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