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Standardisation of Investigations of Mild Bleeding Disorders (MBD)

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ClinicalTrials.gov Identifier: NCT02329899
Recruitment Status : Completed
First Posted : January 1, 2015
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
Françoise Boehlen, MD, 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).

Condition or disease Intervention/treatment
Hemorrhagic Disorders Other: Second step of investigations

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.


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Study Type : Observational
Actual Enrollment : 208 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Standardisation of Investigations of Mild Bleeding Disorders
Study Start Date : July 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

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.

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.

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.




Primary Outcome Measures :
  1. Relative number of precise diagnosis [ Time Frame: 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

  2. Number of biological tests performed per patient [ Time Frame: after the completion of the standardized diagnostic procedure (on average 6 weeks after enrollment) ]
  3. 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 Outcome Measures :
  1. Evaluation of bleeding events [ Time Frame: After one year follow-up ]
    Phone call


Biospecimen Retention:   Samples With DNA
2 aliquots of plasma from 2x 6 ml EDTA blood 2 aliquots of plasma from 2 x 2.7 ml citrate blood 2 aliquots of plasma from 1 x 4 ml heparin blood Storage at -80°C


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients (children or adults) referred to a tertiary care center (haemostasis unit) for investigation of mild bleeding symptoms (with suspicion of mild bleeding disorder)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329899


Locations
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Switzerland
Haemostasis unit, University Hospitals of Geneva
Geneva, Switzerland, 1205
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Boehlen Francoise, MD Haemostasis unit, University Hospitals of Geneva, Switerland

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Responsible Party: Françoise Boehlen, MD, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02329899     History of Changes
Other Study ID Numbers: 10-246
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders
Disease
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases