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OpenTrials
Completed

NCT Number: NCT04553172

Vascular Abnormalities and Bleeding Diathesis

Inherited bleeding disorders (IBD) consist of a heterogeneous group of diseases including coagulation and/or platelets defects and more rarely vascular dysfunctions. A family of four patients suffering from unexplained excessive bleeding has been followed clinically in France for many years. Recently, whole exome sequencing (WES) of DNA allowed the identification of a heterozygous genetic variant which segregated to family members with bleeding diathesis. The aim of the study was to better characterize the phenotype by studying VWF and platelets in affected family members ultimately contributing to the pathogenesis of a bleeding diathesis.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UH Montpellier

Montpellier, 34295, France

About this study

As explained in the brief summary, whole exome sequencing (WES) of DNA was performed in a family of four patients suffering from unexplained excessive bleeding. It allowed the identification of a variant which segregated to family members with bleeding diathesis. Firstly, in vitro, functional analyses were performed in primary human endothelial cells. Then, in-vivo analysis have to be performed on affected patients.

The four related patients suffering from excessive bleeding have been followed clinically in France for many years. During the follow-up of three of these affected patients, biological studies are planned.

Biological assays include:

  • Conventional assessment of primary haemostasis: platelet count, platelet aggregation, functional and antigen measurement of von Willebrand factor.
  • Specific testing: Von Willebrand factor multimeric profile, immunolabeling of platelets.

Conventional assessment is part of the conventional follow-up of patients with inherited bleeding disorder. It will not require any additional blood sample. For specific testing and after informed consent, fresh blood samples of patients will be collected in 1/10 volume of acid-citrate-dextrose and centrifuged for 10 min at 200 g to obtain Platelet-rich plasma (PRP) for functional analysis of platelets and Platelet-poor plasma for the multimerization state of von Willebrand factor. Then, the results will be compared to the in-vitro findings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • members of the family

Exclusion criteria

  • patient who refused to participate

Treatment and study plan

Primary outcomes

  1. platelet count

    Time frame: 1 day

    automatic count of platelet

  2. platelet aggregation

    Time frame: 1 day

    automated assay using adenosine diphosphate (ADP), arachidonic acid (AA) agonists

  3. VWF (von Willebrand factor)

    Time frame: 1 day

    activity/antigen levels measurements

Secondary outcomes

  1. VWF mutimerization status

    Time frame: 1 day

    multimer distribution

  2. immunostaining of platelets

    Time frame: 2 to 3 days

    fixed platelet studies coverslips are challenged with a panel of primary antibodies for immunofluorescence staining

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Endothelial Dysfunction Leads to Bleeding Diathesis

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Sep 17, 2020
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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