Overview

This trial has been completed.

Condition hemorrhagic disorders
Treatment second step of investigations
Sponsor University Hospital, Geneva
Start date July 2012
End date September 2016
Trial size 208 participants
Trial identifier NCT02329899, 10-246

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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
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.
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
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 Outcomes

Measure
Relative number of precise diagnosis
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

Measure
Evaluation of bleeding events
time frame: After one year follow-up

Eligibility Criteria

Male or female participants at least 2 years old.

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.

Additional Information

Official title Standardisation of Investigations of Mild Bleeding Disorders
Principal investigator Boehlen Francoise, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University Hospital, Geneva.