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Sponsors and Collaborators: |
University Hospital, Strasbourg, France Louis Pasteur University, Strasbourg INSERM, U.770 Aventis, Génopôle d'Evry. |
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Information provided by: | University Hospital, Strasbourg, France |
ClinicalTrials.gov Identifier: | NCT00617721 |
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 | Intervention |
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Unexplained Isolated Provoked Hemorrhages Familial Bleeding Disorder Scott Syndrome |
Other: Blood withdrawal |
Study Type: | Observational |
Study Design: | Family-Based, Prospective |
Official Title: | Defect in Cell Stimulation and Unexplained hemorrhagesMarkers Related to Membrane Remodelling in the Prognosis Scott-like Syndormes |
plasma, white cells, DNA (when the family is informative)
Estimated Enrollment: | 125 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
patients with unexplained bleeding disorder
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Other: Blood withdrawal
Observational study. Limited blood withdrawal. Any other intervention will be determined by the patient's clinical status.
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2
healthy volunteers
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Other: Blood withdrawal
Observational study. Limited blood withdrawal. Any other intervention will be determined by the patient's clinical status.
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Ages Eligible for Study: | 2 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Patients with unexplained bleeding disorder
Inclusion Criteria:
Exclusion Criteria:
Contact: Florence TOTI, MD | 33390243986 | florence.toti@hemato-ulp.u-strasbg.fr |
Contact: Jean-Marie FREYSSINET, MD | 33390243986 | jean-marie.freyssinet@hemato-ulp.u-strasbg.fr |
France | |
Laboratoire d'Hématologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg | Recruiting |
STRASBOURG, France, 67098 | |
Contact: Lélia GRUNEBAUM, MD 33388127528 | |
Principal Investigator: Lélia GRUNEBAUM, MD | |
Sub-Investigator: Alice EISCHEN, MD | |
Laboratoire d'Hématologie, Hôpital Robert Debré | Not yet recruiting |
REIMS, France, 51092 | |
Contact: Philippe NGUYEN, MD 33.3.26.78.38.71 pnguyen@chu-reims.fr | |
Principal Investigator: Philippe NGUYEN, MD | |
Laboratoire d'Hémostase et d'Immunologie, Centre Hospitalier | Not yet recruiting |
LE MANS, France, 72037 | |
Contact: Fabienne PINEAU-VINCENT, MD 33.2.43.43.27.78 fpineauvincent@ch-lemans.fr | |
Principal Investigator: Fabienne PINEAU-VINCENT, MD | |
Martinique | |
Service d'Hématologie Biologique, Hôpital Pierre Zobda Quitman | Recruiting |
FORT DE FRANCE, Martinique, 97261 | |
Contact: Claire GONIN, MD 33.3.5.96.55.22.79 claire.gonin@chu-fort-defrance.fr | |
Principal Investigator: Claire GONIN, MD | |
Sub-Investigator: Serge PIERRE-LOUIS, MD | |
Sub-Investigator: Yves PLUMELLE, MD |
Principal Investigator: | Lélia GRUNEBAUM, MD | Hôpitaux Universitaires de Strasbourg |
Responsible Party: | University Hospital, Strasbourg, France ( Emmanuel LAVOUE, Directeur Adjoint de la DRCI ) |
Study ID Numbers: | 3930 |
Study First Received: | February 5, 2008 |
Last Updated: | August 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00617721 History of Changes |
Health Authority: | France: Ministry of Health |
Defective gene(s) in plasma membrane remodelling. Scott syndrome, Reduced prothrombin consumption, Circulating biomakers of scott syndrome |
Thrombin Scott Syndrome Hemorrhage |
Disease Pathologic Processes Syndrome Hemorrhage |