NCT04119908

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
May 2023May 2028

First Submitted

Initial submission to the registry

October 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
3.6 years until next milestone

Study Start

First participant enrolled

May 24, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2028

Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

5 years

First QC Date

October 7, 2019

Last Update Submit

September 1, 2023

Conditions

Von Willebrand DiseasesGlanzmann Thrombasthenia

Keywords

constitutional haemorrhagic diseases, Videomicroscopy, prediction, bleedingVideomicroscopypredictionbleeding

Outcome Measures

Primary Outcomes (1)

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

    at 3 years

Secondary Outcomes (9)

  • Sublingual capillary density

    At baseline

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

    At baseline and at 3 years

  • delta of Sublingual capillary density increase

    between inclusion and end of study (at 3 years)

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

    At baseline, at 3 years

  • delta of increase of ISTH-BAT haemorrhagic score

    between inclusion and end of study (at 3 years)

  • +4 more secondary outcomes

Study Arms (2)

Patients with haemorrhagic disease

EXPERIMENTAL

Patients with von Willebrand disease or Patients with Glanzmann Thrombasthenia

Device: Sublingual videomicroscopyBiological: blood sample

Control group

OTHER

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

Device: Sublingual videomicroscopy

Interventions

Sublingual videomicroscopyDEVICE

Measurement of sublingual capillary density by video microscopy

Control groupPatients with haemorrhagic disease
blood sampleBIOLOGICAL

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

Patients with haemorrhagic disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Social insured patient

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Lille

Lille, Nord, 59000, France

RECRUITING

MeSH Terms

Conditions

von Willebrand DiseasesThrombastheniaHemorrhage

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersBlood Platelet DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Antoine Rauch, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine Rauch, MD,PhD

CONTACT

3 20445962 (poste 29673)antoine.rauch@chru-lille.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2019

First Posted

October 9, 2019

Study Start

May 24, 2023

Primary Completion (Estimated)

May 24, 2028

Study Completion (Estimated)

May 24, 2028

Last Updated

September 7, 2023

Record last verified: 2023-09

Locations

FR(1)