Hemorrhagic DisordersMBDNCT02329899
Standardisation of Investigations of Mild Bleeding Disorders
An observational study of Hemorrhagic Disorders, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Hemorrhagic Disorders
- What is being tested?
- Second step of investigations
- How many people
- 208 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2012to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Haemostasis unit, University Hospitals of Geneva
Geneva, 1205
About this study
Observational study aimed at evaluating the clinical impact of a standardised diagnostic procedure for the investigation of patients with suspected mild bleeding disorder (MBD).
Read the 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:
- The relative number of precise diagnosis (according to recognised classification of haemostatic disorders) in each clinical probability category;
- The number of biological tests performed per patient in each clinical probability category;
- 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
- Hemorrhagic Disorders
- Being tested
- Second step of investigations
- Medical subject headings
- Hemorrhagic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second step of investigationsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Second step of investigations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative number of precise diagnosis
Diagnosis are going to be evaluated according to recognized classification of haemostatic disorders
Measured: after the completion of the standardized diagnostic procedure (on average 6 weeks after enrollment)
Number of biological tests performed per patient
Measured: 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
Measured: 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
Phone call
Measured: After one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startJul 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Françoise Boehlen, MD, University Hospital, Geneva
- Investigators
- Boehlen Francoise, MD, Principal investigator, Haemostasis unit, University Hospitals of Geneva, Switerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329899
- Sponsor's protocol ID
- 10-246
- Acronym
- MBD
- Status last verified
- Nov 2016
- First submitted
- 22 Dec 2014
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardisation of Investigations of Mild Bleeding Disorders
- ClinicalTrials.gov ID
- NCT02329899
- Acronym / sponsor ID
- MBD / 10-246
- Conditions
- Hemorrhagic Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 1 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- The relative number of precise diagnosis (according to recognised classification of haemostatic disorders) in each clinical probability category;
- The number of biological tests performed per patient in each clinical probability category;
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Possible MBD | – | Other: Second step of investigationsDefined 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. |
| MBD unlikely | – | Other: Second step of investigationsPatients 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Second step of investigationsSecond step according to results of the first step: * exploration of coagulation factors; * factor XIII and fibrinolysis investigations; * investigation of platelet function; * investigation of thrombocytopenia. | Other | MBD unlikely, Possible MBD |
Primary outcome
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
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)
1 secondary outcome
Evaluation of bleeding events
Time frame: After one year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehlen Francoise, MD principal investigator
Haemostasis unit, University Hospitals of Geneva, Switerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhagic Disorders, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative number of precise diagnosis (time frame: after the completion of the standardized diagnostic procedure (on average 6 weeks after enrollment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016.