Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic Diseases

NCT ID: NCT04119908

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-24

Study Completion Date

2028-05-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In Willebrand disease, there is currently no test available to identify non-invasively patients with a high risk of bleeding from angiodysplasias The study propose to use a sublingual capillary bed analysis by video-microscopy, a sensitive, reproducible and non-invasive technique, to assess whether sublingual capillary density is predictive of hemorrhagic risk for patients with von Willebrand disease.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Von Willebrand Diseases Glanzmann Thrombasthenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with haemorrhagic disease

Patients with von Willebrand disease or Patients with Glanzmann Thrombasthenia

Group Type EXPERIMENTAL

Sublingual videomicroscopy

Intervention Type DEVICE

Measurement of sublingual capillary density by video microscopy

blood sample

Intervention Type BIOLOGICAL

Collection of citrate tubes of 5 mL at baseline and at 36 months

Control group

Patients with moderate or severe hemophilia A or women carrying the hemophilia gene

Group Type OTHER

Sublingual videomicroscopy

Intervention Type DEVICE

Measurement of sublingual capillary density by video microscopy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sublingual videomicroscopy

Measurement of sublingual capillary density by video microscopy

Intervention Type DEVICE

blood sample

Collection of citrate tubes of 5 mL at baseline and at 36 months

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Social insured patient

Exclusion Criteria

* Minor patient
* Refusal of consent
* Person benefiting from a system of legal protection
* Pregnant patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antoine Rauch, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Lille

Lille, Nord, France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Antoine Rauch, MD,PhD

Role: CONTACT

3 20445962 (poste 29673) ext. +33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Antoine Rauch, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-A01601-56

Identifier Type: OTHER

Identifier Source: secondary_id

2019_05

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Belgian Antithrombin Deficiency Registry
NCT05891899 NOT_YET_RECRUITING