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Clinical Trials/NCT05389007
NCT05389007
Recruiting
Not Applicable

German TTP- Registry- Prospective Cohort of Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP): Pathophysiology, Diagnosis, Treatment and Follow-Up

Johannes Gutenberg University Mainz1 site in 1 country156 target enrollmentJuly 8, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thrombotic Thrombocytopenic Purpura
Sponsor
Johannes Gutenberg University Mainz
Enrollment
156
Locations
1
Primary Endpoint
Predictive markers for morbidity and mortality
Status
Recruiting
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 8, 2016
End Date
July 1, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Johannes Gutenberg University Mainz
Responsible Party
Principal Investigator
Principal Investigator

Charis v. Auer

Head of Hemostaseology, Principal Investigator

Johannes Gutenberg University Mainz

Eligibility Criteria

Inclusion Criteria

  • Patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of
  • 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.

Outcomes

Primary Outcomes

Predictive markers for morbidity and mortality

Time Frame: 3 years

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

Study Sites (1)

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