About this trial
Hereditary thrombotic thrombocytopenic purpura (Upshaw-Schulman syndrome) is a rare disorder characterized by thrombocytopenia as a result of platelet consumption, microangiopathic hemolytic anemia, occlusion of the microvasculature with von Willebrand factor-platelet-thrombic and ischemic end organ damage. The underlying patho-mechanism is a severe congenital ADAMTS13 (a disintegrin and metalloproteinase with thrombospondin type 1 motif, 13) deficiency which is the result of compound heterozygous or homozygous ADAMTS13 gene mutations.
Although considered a monogenic disorder the clinical presentation in Upshaw-Schulman syndrome patients varies considerably without an apparent genotype-phenotype correlation. In 2006 we have initiated a registry for patients with Upshaw-Schulman syndrome and their family members to identify possible triggers of acute bouts of TTP, to document individual clinical courses and treatment requirements as well as possible side effects of long standing plasma substitution, e.g. alloantibody formation or viral infections.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Severe ADAMTS13 deficiency ( ≤ 10% activity) and no ADAMTS 13 inhibitor on two or more occasions at least one month apart
Being a family member of a confirmed or suspected patient
Molecular analysis of ADAMTS13 gene with one or more mutations and/or positive infusion trial (full recovered ADAMTS13 activity after infused fresh frozen plasma (FFP) with a plasma half-life of 2-4 days)
Disqualifiers
None
Trial population
Patients with either confirmed or with suspected hereditary TTP and their family members are eligible for enrollment
Trial design
Case-only
Other
Treatments tested in this trial
Observation
Other interventionNo interventions planned: treatment of patients at the discretion of the treating/responsible physician
Treatment groups
Trial outcomes
Primary outcomes
Clinical presentation and disease course in hereditary TTP
Secondary outcomes
Identification of disease-modifying factors, including genotype-phenotype correlation
Treatment requirements in hereditary TTP patients
Documentation of potential adversary effects of (long-term) plasma treatment
Mortality of hereditary TTP
Sponsors and contacts
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Insel Gruppe AG, University Hospital Bern
Lead sponsor
Swiss National Science Foundation
Collaborator
Mach Gaensslen Foundation
Collaborator
Baxalta Innovations GmbH, Wien, Austria
Collaborator