.German TTP-Registry (Thrombotic Thrombocytopenic Purpura)

Recruiting

• Conditions: Thrombotic Thrombocytopenic Purpura

• Registration Number: NCT05389007
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Study Timeline

• Study Start: 2016-07-08
• Status Verified: 2022-05
• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-20
• Last Update Submitted: 2022-05-20
• Study First Posted: 2022-05-24
• Last Update Posted: 2022-05-24
• Primary Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 156

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Mainz, Hematology; 🇩🇪 Mainz, Germany