.German TTP-Registry (Thrombotic Thrombocytopenic Purpura)

NCT05389007 | Unknown

• 1 other identifier: RGTTP
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombotic Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

It is planned to include all patients with TTP in Germany.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

University Hospital Mainz, Hematology

Mainz, 55131, Germany

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombotic Thrombocytopenic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Thrombophilia; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Charis v. Auer-Wegener

  Universitätsmedizin Mainz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charis v. Auer-Wegener

CONTACT

charis.von-auer@unimedizin-mainz.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hemostaseology, Principal Investigator

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 24, 2022
• Study Start: July 8, 2016
• Primary Completion: July 1, 2025
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)