Unexplained Isolated Provoked HemorrhagesNCT00617721
Markers of Defective Membrane Remodelling in Scott-like Syndromes
An observational study of Unexplained Isolated Provoked Hemorrhages and Familial Bleeding Disorder, run by University Hospital, Strasbourg, France at 5 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Unexplained Isolated Provoked Hemorrhages, Familial Bleeding Disorder, Scott Syndrome
- What is being tested?
- Blood withdrawal
- How many people
- 29 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jun 2008to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with unexplained bleeding disorder
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
France4 sites
Hôpital Antoine Béclère, Service d'Hématologie Biologique
Clamart, 92140
Laboratoire d'Hémostase et d'Immunologie, Centre Hospitalier
Le Mans, 72037
Laboratoire d'Hématologie, Hôpital Robert Debré
Reims, 51092
Laboratoire d'Hématologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098
Martinique1 site
Service d'Hématologie Biologique, Hôpital Pierre Zobda Quitman
Fort-de-France, 97261
About this study
Official title: Defect in Cell Stimulation and Unexplained hemorrhagesMarkers Related to Membrane Remodelling in the Prognosis Scott-like Syndormes
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.
- Being tested
- Blood withdrawal
- Keywords
- Defective gene(s) in plasma membrane remodelling., Scott syndrome,, Reduced prothrombin consumption,, Circulating biomakers of scott syndrome
- Medical subject headings
- Scott Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood withdrawalOther
Observational study. Limited blood withdrawal. Any other intervention will be determined by the patient's clinical status.
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients with unexplained bleeding disorder Receives: Other: Blood withdrawal | |
| 2 | healthy volunteers Receives: Other: Blood withdrawal |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained Isolated Provoked HemorrhagesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Louis Pasteur University, Strasbourg, Institut National de la Santé Et de la Recherche Médicale, France, Aventis, Génopôle d'Evry.
- Responsible party
- Sponsor
- Investigators
- Lélia GRUNEBAUM, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617721
- Sponsor's protocol ID
- 3930
- Status last verified
- Jun 2016
- First submitted
- 5 Feb 2008
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defect in Cell Stimulation and Unexplained hemorrhagesMarkers Related to Membrane Remodelling in the Prognosis Scott-like Syndormes
- ClinicalTrials.gov ID
- NCT00617721
- Acronym / sponsor ID
- 3930
- Keywords
- Defective gene(s) in plasma membrane remodelling., Scott syndrome,, Reduced prothrombin consumption,, Circulating biomakers of scott syndrome
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Louis Pasteur University, Strasbourg, Institut National de la Santé Et de la Recherche Médicale, France, Aventis, Génopôle d'Evry.
- Study start
- Jun 2008
- First posted
- 18 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Blood withdrawalpatients with unexplained bleeding disorder |
| 2 | – | Other: Blood withdrawalhealthy volunteers |
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with unexplained bleeding disorder
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood withdrawalObservational study. Limited blood withdrawal. Any other intervention will be determined by the patient's clinical status. | Other | 1, 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lélia GRUNEBAUM, MD principal investigator
Hôpitaux Universitaires de Strasbourg
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unexplained Isolated Provoked Hemorrhages and Familial Bleeding Disorder, run by University Hospital, Strasbourg, France at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Martinique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.