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Markers of Defective Membrane Remodelling in Scott-like Syndromes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00617721
Recruitment Status : Terminated
First Posted : February 18, 2008
Last Update Posted : June 17, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
Purpose: Identification of the gene(s) involved in plasma membrane remodelling. Identification of the circulating markers affected by the defective membrane remodelling in a collection of families with unexplained provoked hemorrhages and evaluation of their prognosis value in the assessment of the hemostatic cellular response.Hypothesis: Scott syndrome is rare a familial disorder characterized by provoked haemorrages in homozygous-type patients due to isolated membrane remodelling deficiency. Membrane remodelling is necessary for cellular hemostatic responses.

Condition or disease Intervention/treatment
Unexplained Isolated Provoked Hemorrhages Familial Bleeding Disorder Scott Syndrome Other: Blood withdrawal

Study Design

Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Defect in Cell Stimulation and Unexplained hemorrhagesMarkers Related to Membrane Remodelling in the Prognosis Scott-like Syndormes
Study Start Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
patients with unexplained bleeding disorder
Other: Blood withdrawal
Observational study. Limited blood withdrawal. Any other intervention will be determined by the patient's clinical status.
healthy volunteers
Other: Blood withdrawal
Observational study. Limited blood withdrawal. Any other intervention will be determined by the patient's clinical status.

Outcome Measures

Biospecimen Retention:   Samples With DNA
plasma, white cells, DNA (when the family is informative)

Eligibility Criteria

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Ages Eligible for Study:   2 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with unexplained bleeding disorder

Inclusion Criteria:

  • Patients with unexplained provoked hemorrhages (surgery, tooth extraction, birth …), and associated with reduced prothrombin consomption (residual prothrombine in serum > à 5%).
  • Family members of the patients defined above, with or without unexplained hemorrhages (symptomatic or not).
  • Patient's approval based on detailed information given by the pratician

Exclusion Criteria:

  • Patients with primary hemostasis defect or defective blood coagulation factor(s) possibly explaining the bleeding disorder.
  • Anémia,
  • patients known to be affected by Factor V New York .
  • Patients enrolled in a previous clinical study, the exclusion period of which is not yet completed. - Collaboration to the study rejected by the patient
  • Patients that are not registered for medical care social insurance.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617721

Hôpital Antoine Béclère, Service d'Hématologie Biologique
Clamart, France, 92140
Laboratoire d'Hémostase et d'Immunologie, Centre Hospitalier
Le Mans, France, 72037
Laboratoire d'Hématologie, Hôpital Robert Debré
Reims, France, 51092
Laboratoire d'Hématologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67098
Service d'Hématologie Biologique, Hôpital Pierre Zobda Quitman
Fort de France, Martinique, 97261
Sponsors and Collaborators
University Hospital, Strasbourg, France
Louis Pasteur University, Strasbourg
Institut National de la Santé Et de la Recherche Médicale, France
Aventis, Génopôle d'Evry.
Principal Investigator: Lélia GRUNEBAUM, MD Hôpitaux Universitaires de Strasbourg
More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00617721     History of Changes
Other Study ID Numbers: 3930
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016

Keywords provided by University Hospital, Strasbourg, France:
Defective gene(s) in plasma membrane remodelling.
Scott syndrome,
Reduced prothrombin consumption,
Circulating biomakers of scott syndrome

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders