Standardisation of Investigations of Mild Bleeding Disorders (MBD)

Observational study aimed at evaluating the clinical impact of a standardised diagnostic procedure for the investigation of patients with suspected mild bleeding disorder (MBD).

Study Overview

• Status: Completed
• Conditions: Hemorrhagic Disorders
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 208

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • Haemostasis unit, University Hospitals of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of bleeding events	Phone call	After one year follow-up

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Boehlen Francoise, MD, Haemostasis unit, University Hospitals of Geneva, Switerland

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: December 22, 2014
• First Submitted That Met QC Criteria: December 31, 2014
• First Posted (Estimate): January 1, 2015

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhagic Disorders
• Other Study ID Numbers: 10-246