Bleeding DisorderNCT05214300
Screening for Bleeding Disorders in Children
An observational study of Bleeding Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The investigators try to improve the screening of bleeding disorders in children by identifying symptoms, laboratory abnormalities and clinical scores discriminating patients congenital bleeding disorders in order to create a simple screening algorithm applicable in pediatrics, aiming for use in pre-anesthetic… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bleeding Disorder
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2019to 20 Dec 2021
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children 0-18 years old
Who may be able to join
- referred by their general practitioner or another caring physician for evaluation of bleeding symptoms
- abnormal laboratory test results or family study
- the patient being the first-degree relative of a patient with a known bleeding disorder.
Who cannot join
- older than 18 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Bleeding Disorders in Children: Evaluation of the Elements of the Interrogation, the Screening Workup and the Clinical Scores
The investigators try to improve the screening of bleeding disorders in children by identifying symptoms, laboratory abnormalities and clinical scores discriminating patients congenital bleeding disorders in order to create a simple screening algorithm applicable in pediatrics, aiming for use in pre-anesthetic consultation and in consultation by pediatricians and general practitioners.
Read the detailed description
Objective : To determine simple clinical and biological factors that can improve the screening of hemostatic diseases at risk of hemorrhage in children.
Method:
- Retrospective inclusion of all patients <18 years referred to the CRTH in pediatric consultation for the reason of exploration of a hemorrhagic syndrome or exploration of an anomaly in the hemostasis assessment.
- Data collected (by collection in the medical file):
Patient data: Age, sex, personal and family history of hemorrhagic disease
Clinical data: hemorrhagic symptomatology (epistaxis, gingivorrhagia, etc.) Biological data: PT, TCK, factor assay, platelet function Medical data: complete diagnosis if diagnosis of hemorrhagic disease
- Scores: HEMOSTOP, PBQ, ISTH, TOSETTO score
- Analyzes: calculation of the Odd Ratio, AUC, Se, Sp, VPP, VPN for different clinical / biological factors and each score.
- Conditions
- Bleeding Disorder
- Keywords
- von Willebrand disease, hemophilia A and B, other coagulant factor deficiencies
- Medical subject headings
- Hemostatic Disorders, von Willebrand Diseases, Hemophilia A
What is being measured
The primary outcome is the main question the study is designed to answer.
Observe the correlation between the data of the interrogation
Observe the correlation between the data of the interrogation, the clinical examination and the clinical history and the demonstration of a confirm congenital bleeding disorder.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Dec 2019
- Primary completion1 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding DisorderStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre THERON, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214300
- Sponsor's protocol ID
- RECHMPL21_0648
- Status last verified
- Dec 2021
- First submitted
- 24 Dec 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Bleeding Disorders in Children: Evaluation of the Elements of the Interrogation, the Screening Workup and the Clinical Scores
- ClinicalTrials.gov ID
- NCT05214300
- Acronym / sponsor ID
- RECHMPL21_0648
- Conditions
- Bleeding Disorder
- Keywords
- von Willebrand disease, hemophilia A and B, other coagulant factor deficiencies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 28 Jan 2022 (actual)
- 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.
The investigators try to improve the screening of bleeding disorders in children by identifying symptoms, laboratory abnormalities and clinical scores discriminating patients congenital bleeding disorders in order to create a simple screening algorithm applicable in pediatrics, aiming for use in pre-anesthetic consultation and in consultation by pediatricians and general practitioners.
Detailed description
Objective : To determine simple clinical and biological factors that can improve the screening of hemostatic diseases at risk of hemorrhage in children.
Method:
- Retrospective inclusion of all patients <18 years referred to the CRTH in pediatric consultation for the reason of exploration of a hemorrhagic syndrome or exploration of an anomaly in the hemostasis assessment.
- Data collected (by collection in the medical file):
Patient data: Age, sex, personal and family history of hemorrhagic disease
Clinical data: hemorrhagic symptomatology (epistaxis, gingivorrhagia, etc.) Biological data: PT, TCK, factor assay, platelet function Medical data: complete diagnosis if diagnosis of hemorrhagic disease
- Scores: HEMOSTOP, PBQ, ISTH, TOSETTO score
- Analyzes: calculation of the Odd Ratio, AUC, Se, Sp, VPP, VPN for different clinical / biological factors and each score.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children 0-18 years old
Key inclusion criteria (3 listed)
- referred by their general practitioner or another caring physician for evaluation of bleeding symptoms
- abnormal laboratory test results or family study
- the patient being the first-degree relative of a patient with a known bleeding disorder.
Key exclusion criteria (1 listed)
- older than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Observe the correlation between the data of the interrogation
Time frame: 1 day
Observe the correlation between the data of the interrogation, the clinical examination and the clinical history and the demonstration of a confirm congenital bleeding disorder.
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 28 Jan 2022.
- Individual participant dataSharing planned: Undecided. NC
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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.
Alexandre THERON study director
University Hospital, Montpellier
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 Bleeding Disorder, run by University Hospital, Montpellier at 1 site in France.
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 3 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 28 Jan 2022. 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 France. 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?
Observe the correlation between the data of the interrogation (time frame: 1 day). 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 28 Jan 2022.