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Standardisation of Investigations of Mild Bleeding Disorders

NCT ID: NCT02329899

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Hemorrhagic Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Possible MBD

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.

Second step of investigations

Intervention Type OTHER

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.

MBD unlikely

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.

Second step of investigations

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Françoise Boehlen, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Boehlen Francoise, MD

Role: PRINCIPAL_INVESTIGATOR

Haemostasis unit, University Hospitals of Geneva, Switerland

Locations

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Haemostasis unit, University Hospitals of Geneva

Geneva, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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10-246

Identifier Type: -

Identifier Source: org_study_id