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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05389007
Recruitment Status : Recruiting
First Posted : May 24, 2022
Last Update Posted : May 24, 2022
Sponsor:
Information provided by (Responsible Party):
Charis v. Auer, 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.

Condition or disease
Thrombotic Thrombocytopenic Purpura

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.

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Study Type : Observational
Enrollment : 156 participants
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 : July 8, 2016
Estimated Primary Completion Date : July 1, 2025





Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
It is planned to include all patients with TTP in Germany.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05389007


Contacts
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Contact: Charis v. Auer-Wegener charis.von-auer@unimedizin-mainz.de

Locations
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Germany
University Hospital Mainz, Hematology Recruiting
Mainz, Germany, 55131
Contact: Charis v. Auer-Wegener       charis.von-auer@unimedizin-mainz.de   
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
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Principal Investigator: Charis v. Auer-Wegener Universitätsmedizin Mainz
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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    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Purpura
Purpura, Thrombocytopenic
Purpura, Thrombotic Thrombocytopenic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Thrombophilia