.German TTP-Registry (Thrombotic Thrombocytopenic Purpura)

Thrombotic Thrombocytopenic Purpura Clinical Trial

— RGTTP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05389007
• Other study ID #: RGTTP
• Status: Recruiting
• Start date: July 8, 2016

Study information

• Verified date: May 2022
• Source: Johannes Gutenberg University Mainz
• Contact: Charis v. Auer-Wegener
• Email: charis.von-auer[@]unimedizin-mainz.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombotic Thrombocytopenic
• Thrombotic Thrombocytopenic Purpura

Locations

Country	Name	City	State
Germany	University Hospital Mainz, Hematology	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive markers for morbidity and mortality	Identification of predictive markers for morbidity and mortality in acute TTP and in TTP relapses using a prospective long-term registry	3 years