.German TTP-Registry (Thrombotic Thrombocytopenic Purpura)

NCT ID: NCT05389007

Last Updated: 2022-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-08

Brief Summary

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Open, multi-center, observational, prospective cohort study, only disease-indicated treatment, in patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of 18 for 1.) prospective investigation of patients with TTP in an acute bout and during long-term follow and 2.) assessment of prevalence, course of disease, success of therapy, possible triggers for relapses and possibilities for better diagnosis and prognosis.

Detailed Description

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1.) Identification of predictive markers for morbidity and mortality in acute TTP and in TTP relapses using a prospective long-term registry and 2.) Investigation of the pathophysiological processes in acute bouts and in remission by recording the clinical symptoms and diagnostics for a better understanding of the course of the disease, optimization of diagnostic procedures and their correlation with the clinical course, recording of therapy response of all therapeutic options in acute bouts, observation of current treatment options to evaluate outcome and prognostic markers and recording of clinical and laboratory chemical data during follow-up to assess long-term morbidity.

Conditions

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Thrombotic Thrombocytopenic Purpura

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of 18.
* Patients incapable to give consent, who are accompanied by a legal representative during admission to the study, after the written informed consent of the legal representative.
* Written informed consent of the patient.

Exclusion Criteria

* Patients who are not able to understand the German or English language.
* Patients who are permanently unable to communicate and who are not accompanied by a legal representative.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Charis v. Auer

Head of Hemostaseology, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charis v. Auer-Wegener

Role: PRINCIPAL_INVESTIGATOR

Universitätsmedizin Mainz

Locations

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University Hospital Mainz, Hematology

Mainz, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Charis v. Auer-Wegener

Role: CONTACT

Facility Contacts

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Charis v. Auer-Wegener

Role: primary

Other Identifiers

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RGTTP

Identifier Type: -

Identifier Source: org_study_id

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