RGTTP: .German TTP-Registry (Thrombotic Thrombocytopenic Purpura)

Sponsor
Johannes Gutenberg University Mainz (Other)
Overall Status
Recruiting
CT.gov ID
NCT05389007
Collaborator
(none)
156
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    German TTP- Registry- Prospective Cohort of Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP): Pathophysiology, Diagnosis, Treatment and Follow-Up
    Study Start Date :
    Jul 8, 2016
    Anticipated Primary Completion Date :
    Jul 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Predictive markers for morbidity and mortality [3 years]

      Identification of predictive markers for morbidity and mortality in acute TTP and in TTP relapses using a prospective long-term registry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Mainz, Hematology Mainz Germany 55131

    Sponsors and Collaborators

    • Johannes Gutenberg University Mainz

    Investigators

    • Principal Investigator: Charis v. Auer-Wegener, Universitätsmedizin Mainz

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Charis v. Auer, Head of Hemostaseology, Principal Investigator, Johannes Gutenberg University Mainz
    ClinicalTrials.gov Identifier:
    NCT05389007
    Other Study ID Numbers:
    • RGTTP
    First Posted:
    May 24, 2022
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 24, 2022