Status:
UNKNOWN
Study of Patients With Thrombotic Microangiopathy Associated With Mitomycin C, Treated or Not With Eculizumab
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Thrombotic Microangiopathies
Eligibility:
All Genders
18+ years
Brief Summary
Thrombotic microangiopathies (TMA) are defined as a triad combining mechanical hemolytic anemia, peripheral thrombocytopenia and ischemic organ damage. Mitomycin C is an alkylating agent used as chem...
Eligibility Criteria
Inclusion
- Adult patients (\>=18 years)
- Having received treatment with mitomycin C (regardless of the method of administration and indication) between 01/01/1990 and 12/31/2023
- and having developed a picture of thrombotic microangiopathy attributed to mitomycin C:
- biological: defined as: thrombocytopenia \<150G/L and mechanical hemolytic anemia (at least 3 out of 4 criteria: hemoglobin \< 12g/dL, presence of schistocytes in blood smear, LDH \> 1N, collapsed haptoglobin (\< lower limit of the limit of laboratory normal)
- or renal: pathological diagnosis of thrombotic microangiopathy on renal biopsy
- having received or not treatment for the episode of microangiopathy, including or not complement inhibitors (Eculizumab).
- Subject not opposing, after information, the reuse of their data for the purposes of this research
Exclusion
- Subject having expressed opposition to participating in the study
- Test for positive Shiga toxin
- ADAMST13 activity \<10%
- Thrombotic microangiopathy attributed to metastatic cancer (infiltration of bone marrow or circulating erythroblasts)
- Impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)
- Subject under judicial protection
- Subject under guardianship or curatorship
Key Trial Info
Start Date :
June 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 7 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06098378
Start Date
June 7 2023
End Date
June 7 2025
Last Update
October 24 2023
Active Locations (1)
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1
Service de Néphrologie, Dialyse et Transplantation - CHU de Strasbourg - France
Strasbourg, France, 67091