Standardisation of Investigations of Mild Bleeding Disorders

NCT02329899 | Completed

• 1 other identifier: 10-246
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

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).

Conditions

Hemorrhagic Disorders

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

Secondary Outcomes (1)

• Evaluation of bleeding events

  After one year follow-up

Study Arms (2)

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

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

Interventions

Second step of investigations 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; Possible MBD

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Haemostasis unit, University Hospitals of Geneva

Geneva, 1205, Switzerland

Location

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

MeSH Terms

Conditions

Hemorrhagic Disorders

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Boehlen Francoise, MD

  Haemostasis unit, University Hospitals of Geneva, Switerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: January 1, 2015
• Study Start: July 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 4, 2016

Record last verified: 2016-11

Locations

CH (1)