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Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic Diseases (VIDEO-BLEED)

Primary Purpose

Von Willebrand Diseases, Glanzmann Thrombasthenia

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Sublingual videomicroscopy

blood sample

About this trial

This is an interventional diagnostic trial for Von Willebrand Diseases focused on measuring constitutional haemorrhagic diseases, Videomicroscopy, prediction, bleeding, Videomicroscopy, prediction, bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patient with a significant form of von Willebrand disease (according to the inclusion criteria of the Willebrand Disease French Reference Center), a Glanzmann Thrombasthenia, a moderate to severe Haemophilia A or a woman carrying the hemophilia gene
Social insured patient

Exclusion Criteria:

Minor patient
Refusal of consent
Person benefiting from a system of legal protection
Pregnant patient

Sites / Locations

CHU de LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Patients with haemorrhagic disease

Control group

Arm Description

Patients with von Willebrand disease or Patients with Glanzmann Thrombasthenia

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

Outcomes

Primary Outcome Measures

area under the ROC curve from Sublingual capillary density to inclusion for the event "existence of at least a clinically significant haemorrhage"

Secondary Outcome Measures

Sublingual capillary density

To compare the sublingual capillary density of patients with von Willebrand disease to that of 3 other groups of patients: with a severe form of hemophilia A with a moderate form of hemophilia A women carrying the hemophilia gene

qualitative abnormalities of sublingual capillaries (capillary haemorrhage, capillary dystrophy)

presence or absence of qualitative abnormalities

delta of Sublingual capillary density increase

ISTH-BAT haemorrhagic score (International Society on Thrombosis and Hemostasis - Bleeding Assessment Tool)

ISTH-BAT is a questionnaire minimum score ranges from 0 to 10 whereas maximum score ranges from 20 to 30

delta of increase of ISTH-BAT haemorrhagic score

ISTH-BAT is a questionnaire minimum score ranges from 0 to 10 whereas maximum score ranges from 20 to 30

plasma levels of proangiogenic markers

dosage of angiopoietin-1, angiopoetin-2 (pg/mL) measured by ELISA

plasma levels of galectine

galectin-1 and galectin-3 measured by ELISA

plasma levels of VEGF

Concentration (pg/ml) of Vascular Endothelial Growth Factor (VEGF) in blood measured by ELISA

delta of increase in plasma levels of all proangiogenic markers

Full Information

NCT ID

NCT04119908

First Posted

October 7, 2019

Last Updated

September 1, 2023

Sponsor

University Hospital, Lille

1. Study Identification

Unique Protocol Identification Number

NCT04119908

Brief Title

Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic Diseases

Acronym

VIDEO-BLEED

Official Title

Interest of Sublingual Videomicroscopy for the Prediction of Bleeding in Von Willebrand Disease and Other Constitutional Haemorrhagic Diseases

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 24, 2023 (Actual)

Primary Completion Date

May 24, 2028 (Anticipated)

Study Completion Date

May 24, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Von Willebrand Diseases, Glanzmann Thrombasthenia

Keywords

constitutional haemorrhagic diseases, Videomicroscopy, prediction, bleeding, Videomicroscopy, prediction, bleeding

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with haemorrhagic disease

Arm Type

Experimental

Arm Description

Patients with von Willebrand disease or Patients with Glanzmann Thrombasthenia

Arm Title

Control group

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Sublingual videomicroscopy

Intervention Description

Measurement of sublingual capillary density by video microscopy

Intervention Type

Biological

Intervention Name(s)

blood sample

Intervention Description

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

Primary Outcome Measure Information:

Title

area under the ROC curve from Sublingual capillary density to inclusion for the event "existence of at least a clinically significant haemorrhage"

Time Frame

at 3 years

Secondary Outcome Measure Information:

Title

Sublingual capillary density

Description

Time Frame

At baseline

Title

qualitative abnormalities of sublingual capillaries (capillary haemorrhage, capillary dystrophy)

Description

presence or absence of qualitative abnormalities

Time Frame

At baseline and at 3 years

Title

delta of Sublingual capillary density increase

Time Frame

between inclusion and end of study (at 3 years)

Title

ISTH-BAT haemorrhagic score (International Society on Thrombosis and Hemostasis - Bleeding Assessment Tool)

Description

ISTH-BAT is a questionnaire minimum score ranges from 0 to 10 whereas maximum score ranges from 20 to 30

Time Frame

At baseline, at 3 years

Title

delta of increase of ISTH-BAT haemorrhagic score

Description

ISTH-BAT is a questionnaire minimum score ranges from 0 to 10 whereas maximum score ranges from 20 to 30

Time Frame

between inclusion and end of study (at 3 years)

Title

plasma levels of proangiogenic markers

Description

dosage of angiopoietin-1, angiopoetin-2 (pg/mL) measured by ELISA

Time Frame

at inclusion and end-of-study visits(at 3 years)

Title

plasma levels of galectine

Description

galectin-1 and galectin-3 measured by ELISA

Time Frame

at inclusion and end-of-study visits(at 3 years)

Title

plasma levels of VEGF

Description

Concentration (pg/ml) of Vascular Endothelial Growth Factor (VEGF) in blood measured by ELISA

Time Frame

at inclusion and end-of-study visits(at 3 years)

Title

delta of increase in plasma levels of all proangiogenic markers

Time Frame

At inclusion and end of study (at 3 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patient with a significant form of von Willebrand disease (according to the inclusion criteria of the Willebrand Disease French Reference Center), a Glanzmann Thrombasthenia, a moderate to severe Haemophilia A or a woman carrying the hemophilia gene Social insured patient Exclusion Criteria: Minor patient Refusal of consent Person benefiting from a system of legal protection Pregnant patient

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Antoine Rauch, MD,PhD

Phone

3 20445962 (poste 29673)

Ext

+33

antoine.rauch@chru-lille.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antoine Rauch, MD,PhD

Organizational Affiliation

University Hospital, Lille

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Lille

City

Lille

State/Province

Nord

ZIP/Postal Code

59000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antoine Rauch, MD

First Name & Middle Initial & Last Name & Degree

Antoine Rauch, md

12. IPD Sharing Statement

Learn more about this trial

Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic Diseases

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