Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT05785468
Eligibility Criteria:
Inclusion Criteria:
* 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 \[19\] for centers that did not measure the ADAMTS13 level.
Exclusion Criteria:
* Patients treated with uncertain aTTP diagnosis according to the above inclusion criteria - Patients manifesting clinical signs like aTTP but characterized by a different pathogenesis (e.g. cancer, sepsis)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05785468
Study Brief:
Protocol Section:
NCT05785468