Familial Bleeding Disorder Clinical Trial
Official title:
Defect in Cell Stimulation and Unexplained hemorrhagesMarkers Related to Membrane Remodelling in the Prognosis Scott-like Syndormes
| NCT number | NCT00617721 |
| Other study ID # | 3930 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | February 5, 2008 |
| Last updated | June 16, 2016 |
| Start date | June 2008 |
| Verified date | June 2016 |
| Source | University Hospital, Strasbourg, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 29 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 2 Years to 80 Years |
| Eligibility |
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. |
Observational Model: Family-Based, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Antoine Béclère, Service d'Hématologie Biologique | Clamart | |
| France | Laboratoire d'Hémostase et d'Immunologie, Centre Hospitalier | Le Mans | |
| France | Laboratoire d'Hématologie, Hôpital Robert Debré | Reims | |
| France | Laboratoire d'Hématologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg | Strasbourg | |
| Martinique | Service d'Hématologie Biologique, Hôpital Pierre Zobda Quitman | Fort de France |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France | Aventis, Génopôle d'Evry., Institut National de la Santé Et de la Recherche Médicale, France, Louis Pasteur University, Strasbourg |
France, Martinique,