Diagnostic of Chronic Thrombocytopenia
DIATROC
Development of an Approach for the Differential Diagnosis of Chronic Idiopathic Thrombocytopenic Purpura and Congenital Thrombocytopenia
1 other identifier
observational
158
0 countries
N/A
Brief Summary
The objective of this study is to provide simple and relevant clinical and biological elements to distinguish a possible Congenital Thrombocytopenia from a Chronic Idiopathic Thrombocytopenic Purpura .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2009
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2012
CompletedFirst Submitted
Initial submission to the registry
August 23, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedAugust 28, 2019
August 1, 2019
2.3 years
August 23, 2019
August 26, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Modelization of congenital thrombocytopenia test
Taking into account the clinical and biological data of patients (flow cytometry and electron microscopy), validation using resampling methods (bootstrap, jacknife, cross validation ...)
AT the screening
Modelization of chronic idiopathic thrombocytopenic purpura test
Taking into account the clinical and biological data of patients (flow cytometry and electron microscopy), validation using resampling methods (bootstrap, jacknife, cross validation ...)
AT the screening
Interventions
1 dry tube of 5 ml, 3 citrated tubes of 5 ml, 1 tube citrate dextrose acid of 7 ml
Eligibility Criteria
Congenital Thrombocytopenia Patients and Chronic Idiopathic Thrombocytopenic Purpura Patients
You may qualify if:
- All patients with chronic thrombocytopenia (\> 6 months) between 10 and 150 G / L, regardless of age or gender,
- Subjects with a definite Chronic Idiopathic thrombocytopenic purpuras, - Subjects with a certain degree of certainty, sometimes pre-identified and already known at the level of the C reactive protein,
- Subjects with chronic thrombocytopenia of undetermined origin, not definitively entering one of the 2 groups mentioned above.
You may not qualify if:
- Thrombocytopenia less than 6 months old;
- Patients with thrombocytopenia related to a viral or chronic infectious pathology (HIV infections or hepatitis C virus, bacterial infections with Helicobacter pillory, for example), an autoimmune disease, in particular systemic lupus and / or antiphospholipid syndrome, a bleeding disorder such as a Intra-vascular Disseminated coagulation, thrombotic microangiopathy, hypersplenism, a responsible medication intake, myelodysplastic syndrome, a pregnancy in progress.
- Patients should not be treated with Immunoglobulin IV, rituximab or anti-CD20 less than 30 days before the date of collection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
1 dry tube of 5 ml, 3 citrated tubes of 5 ml, 1 tube citrate dextrose acid of 7 ml
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paquita NURDEN, Dr
University Hospital, Bordeaux
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2019
First Posted
August 28, 2019
Study Start
November 25, 2009
Primary Completion
March 12, 2012
Study Completion
March 12, 2012
Last Updated
August 28, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share