Thrombotic Thrombocytopenic Purpura Clinical Trial
— MATRISKOfficial title:
Identification of Early Predictive Factors of Cardiac and Cerebral Involvement in Thrombotic Microangiopathies
NCT number | NCT02134171 |
Other study ID # | p120118 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 10, 2014 |
Est. completion date | July 30, 2017 |
Verified date | July 2019 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to determine the frequency of cardiac and cerebral involvements in
patients with idiopathic thrombotic microangiopathies on diagnosis. Patients will be assessed
for cardiac involvement (troponin Ic level and cardiac ultrasonography) and cerebral
involvement (cerebral MRI). The investigators will assess whether serum troponin Ic on
diagnosis can predict morbidity and mortality of patients with a thrombotic microangiopathy
at the acute phase.
The primary outcome measurement is the event free survival at day 30, as defined by death,
myocardial ischemia, arrhythmia, severe cerebral injury and disease exacerbation. An increase
in troponin Ic on diagnosis is defined as at least one result above 0.2 ng/ml among the three
daily analyses performed after TMA diagnosis.
Status | Completed |
Enrollment | 119 |
Est. completion date | July 30, 2017 |
Est. primary completion date | July 4, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - A diagnosis of thrombotic microangiopathy on the following criteria : - A microangiopathic haemolytic anaemia (Hb< 12 g/dl, with presence of schistocytes on blood smear); - A thrombocytopenia <150 G/l; - No associated (precipitating) disease (HIV infection, cancer, chemotherapy, transplantation) or pregnancy; - A written consent obtained from the patient, or from a relative for patients unable to provide the informed consent (because of cerebral involvement for example); - Affiliation at the social insurance regimen. - Major person Exclusion Criteria: - A TMA associated with an associated condition: infection with HIV (HIV) in AIDS stage, , chemotherapy, malignancy, transplantation, or pregnancy. |
Country | Name | City | State |
---|---|---|---|
France | Saint Antoine | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 30-day event-free survival | Events include death or myocardial infarction, arrhythmia, cerebral involvement and exacerbation. Serum troponin Ic is assessed daily the 3 first days following diagnosis. Cardiac ultrasonography is performed within the 4 days following diagnosis and cerebral MRI is performed within the 7 days following the diagnosis. | At 30 days | |
Secondary | Cardiac trouble frequency and type at diagnosis | From day 1 to day 3 after diagnosis | ||
Secondary | Cerebral trouble frequency and type at diagnosis | From day 1 and day 7 after diagnosis | ||
Secondary | Comparison of cerebral and cardiac trouble at diagnosis between thrombotic microangiopathies type | Baseline | ||
Secondary | Description of cardiac and cerebral sequelae at M6 and reversibility frequency of diagnosis cardiac and cerebral lesions at M6 | At 6 months | ||
Secondary | Determination of cardiac and cerebral sequelae prognostic factors at M6 | At 6 months |
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