Status:
UNKNOWN
A Retrospective, Observational Study on the Response to Caplacizumab Treatment in aTTP Patients: the Italian Experience (ROSCAPLI)
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Thrombotic Thrombocytopenic Purpura, Acquired
Eligibility:
All Genders
18+ years
Brief Summary
This study is a multicenter, retrospective, observational study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) treated with plasma exchange (PEX) in association with caplacizumab...
Detailed Description
This study is a multicenter, retrospective, observational study in patients with acquired thrombotic thrombocytopenic purpura (aTTP) treated with plasma exchange (PEX) in association with caplacizumab...
Eligibility Criteria
Inclusion
- The patients included in this study should have received caplacizumab for treatment in the period between Q4-2019 and the end of February 2021 while the end of follow up observation is scheduled for Q1-2021 (to observe at least one month of post treatment follow up). The diagnosis should be based on either clinical/laboratory parameters inclusive of measurement of ADAMTS13 level \<10%) or the PLASMIC score (platelets, lysis, active cancer, stem cell or solid organ transplant, MCV, INR, and creatinine) with intermediate and high risk (sore\>5) already computed or retrospectively calculated as previously detailed for centers that did not measure the ADAMTS13 level.
Exclusion
- Patients treated with uncertain aTTP diagnosis according to the above inclusion criteria and manifesting clinical signs like aTTP but characterized by a different pathogenesis (e.g. cancer, sepsis)
Key Trial Info
Start Date :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05262881
Start Date
March 1 2022
End Date
October 30 2022
Last Update
March 2 2022
Active Locations (1)
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1
Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Rome, Italy, 00168