NCT05152238

Brief Summary

The objective of this ITP registry is to collect clinical information, including biosampling, from consenting patients with a variety of ITPs at different points in the course of their disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

64 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Nov 2021Apr 2027

First Submitted

Initial submission to the registry

November 23, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

November 29, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

4.8 years

First QC Date

November 23, 2021

Last Update Submit

July 10, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • epidemiological data on ITP - Incidence

    Incidence: number of reported ITP, estimate incidence by zip code area

    At enrollment

  • epidemiological data on ITP - Age

    Age (year of birth)

    At enrollment

  • epidemiological data on ITP - Sex distribution

    Sex distribution: female, male

    At enrollment

  • Description of the causes of ITP

    causes of ITP in primary/secondary form (medical induced, autoimmune disease, Lymphoma / malignancy, infection, upon vaccination, others)

    At enrollment

  • ITP treatment type received

    Medical therapies received

    5 years

  • Remission

    Remission Status

    5 years

Secondary Outcomes (12)

  • Recording of clinical characteristics of affected patients - Disease stage

    At enrollment, 6 months, annually up to 5 years

  • Recording of clinical characteristics of affected patients- platelet counts

    At enrollment, 6 months, annually up to 5 years

  • Recording of clinical characteristics of affected patients -disease manifestation at diagnosis

    At enrollment

  • Bleeding events

    At enrollment, 6 months, annually up to 5 years

  • thromboembolic events

    At enrollment, 6 months, annually up to 5 years

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Immune thrombocytopenia (ITP) which is a rare hematologic disorder that can lead to a greater risk of bleeding or a prolonged bleeding time due to an autoimmune-mediated deficiency of platelets. There is a distinction between a primary form, in which no triggering cause is identifiable, and secondary forms, which may for example occur in the context of systemic autoimmune diseases or drug-induced.

You may qualify if:

  • Primary or secondary Immune Thrombocytopenia (ITP)
  • Age ≥18 years
  • signed declaration of consent

You may not qualify if:

  • diagnoses that cannot be reconciled with the diagnosis of ITP (esp. heparin-induced thrombocytopenia, pregnancy-associated thrombocytopenia, pseudothrombocytopenia)
  • no informed consent possible (this covers patients who are unable to understand the nature and scope of participation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (64)

Universitätsklinikum Aachen AöR

Aachen, 52074, Germany

RECRUITING

Klinikum Altenburger Land GmbH, Klinik für Innere Medizin/Hämatologie/Onkologie

Altenburg, 04600, Germany

RECRUITING

MVZ am Klinikum Aschaffenburg

Aschaffenburg, 63739, Germany

RECRUITING

MVZ IMD GmbH, IMD Gerinnungszentrum Hochtaunus

Bad Homburg, 61352, Germany

RECRUITING

Onkologie/Hämatologie

Bad Liebenwerda, 04924, Germany

RECRUITING

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

RECRUITING

Praxis für Hämatologie und Onkologie Berlin-Mitte

Berlin, 10117, Germany

RECRUITING

Vivantes Netzwerk für Gesundheit GmbH, Klinikum am Friedrichshain

Berlin, 10249, Germany

RECRUITING

Onkologie am Segelfliegerdamm

Berlin, 12487, Germany

RECRUITING

MVZ Hämatologikum GmbH

Biberach, 88400, Germany

RECRUITING

Augusta-Kranken-Anstalt gGmbH

Bochum, 44791, Germany

RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, 09116, Germany

RECRUITING

MVZ Klinikum Coburg GmbH

Coburg, 96450, Germany

RECRUITING

Klinikum Darmstadt

Darmstadt, 64283, Germany

NOT YET RECRUITING

ARGE e.V.

Donauwörth, 86609, Germany

RECRUITING

Onkozentrum Dresden/Freiberg

Dresden, 01127, Germany

RECRUITING

Gemeinschaftspraxis Hämatologie-Onkologie

Dresden, 01307, Germany

RECRUITING

Gemeinschaftspraxis Mohm & Prange-Krex

Dresden, 01307, Germany

RECRUITING

Universitätsklinikum Dresden

Dresden, 01307, Germany

RECRUITING

Krankenhaus Düren gGmbH

Düren, 52351, Germany

RECRUITING

Onkologische Praxis Erfurt

Erfurt, 99084, Germany

RECRUITING

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

RECRUITING

MVZ für Hämatologie und Onkologie Essen

Essen, 45136, Germany

RECRUITING

Universitätsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

RECRUITING

Haemostas-Frankfurt

Frankfurt am Main, 60596, Germany

RECRUITING

PIOH Studien und Management GbR

Frechen, 50226, Germany

RECRUITING

Fachärztliche Gemeinschaftspraxis Panagiotou/Minaei

Garbsen, 30823, Germany

RECRUITING

IOGP Gera MVZ GmbH

Gera, 07548, Germany

RECRUITING

ALB FILS Kliniken, Klinik am Eichert

Göppingen, 73035, Germany

RECRUITING

Universitätsklinik Greifswald

Greifswald, 17475, Germany

RECRUITING

Katholisches Krankenhaus Hagen gGmbH

Hagen, 58097, Germany

RECRUITING

Gemeinschaftspraxis, FA für Innere Medizin

Halle, 06110, Germany

RECRUITING

MVZ III Onkologie der evidia MVZ Halle (Saale) GmbH

Halle, 06110, Germany

RECRUITING

Onko-Kolleg GmbH & Co. KG, HOPA MVZ GmbH

Hamburg, 22767, Germany

RECRUITING

Werlhof-Institut MVZ GmbH

Hanover, 30159, Germany

RECRUITING

Onkologie am Raschplatz

Hanover, 30161, Germany

RECRUITING

Dres. Kamal & Dorn GbR

Hanover, 30625, Germany

RECRUITING

ODZ-Petersen GmbH

Heidenheim, 89522, Germany

RECRUITING

St. Bernward Krankenhaus GmbH

Hildesheim, 31134, Germany

RECRUITING

Klinikum Idar-Oberstein GmbH

Idar-Oberstein, 55743, Germany

RECRUITING

University Hospital Jena

Jena, 07745, Germany

RECRUITING

Klinikum Kassel GmbH

Kassel, 34125, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein

Kiel, 24105, Germany

RECRUITING

Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin

Koblenz, 56073, Germany

RECRUITING

Ambulantes Zentrum für Hämatologie, Onkologie und Gerinnung

Kronach, 96317, Germany

RECRUITING

MVZ mbH, Onkologische Schwerpunktpraxis

Leer, 26789, Germany

RECRUITING

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

RECRUITING

OnkoFor Leipzig GmbH

Leipzig, 04289, Germany

RECRUITING

Universitätsklinikum Magdeburg, Klinik für Hämatologie, Onkologie und Zelltherapie

Magdeburg, 39120, Germany

RECRUITING

Carl-von-Basedow Klinikum Merseburg

Merseburg, 06217, Germany

RECRUITING

Gemeinschaftspraxis Hämato-Onkologie

München, 81241, Germany

RECRUITING

Dietrich-Bonhoeffer-Klinikum Neubrandenburg

Neubrandenburg, 17036, Germany

RECRUITING

MVZ Onko Medical GmbH Neustadt

Neustadt am Rübenberge, 31535, Germany

RECRUITING

Pi.Tri.-Studien GmbH

Offenburg, 77654, Germany

RECRUITING

Elblandkliniken Stiftung & Co. KG, Elblandklinikum Riesa

Riesa, 01589, Germany

RECRUITING

Klinikum Südstadt Rostock

Rostock, 18059, Germany

RECRUITING

Medcenter Nordsachsen

Schkeuditz, 04435, Germany

RECRUITING

MVZ am Schlossgarten, Zero Praxen

Schwetzingen, 68723, Germany

RECRUITING

Onkologiezentrum Soest/Iserlohn

Soest, 59494, Germany

RECRUITING

Bundeswehrkrankenhaus Ulm

Ulm, 89081, Germany

RECRUITING

Schwarzwald-Baar. Klinikum Villingen-Schwenningen GmbH

Villingen-Schwenningen, 78052, Germany

RECRUITING

Onkologisches Zentrum Wolfsburg-Helmstadt MVZ GmbH

Wolfsburg, 38440, Germany

RECRUITING

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

RECRUITING

Praxis für Hämatologie und Internistische Onkologie

Zittau, 02763, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

18 mL whole blood (peripheral venipuncture) and 9 ml bone marrow

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Thomas Stauch, Dr. med.

    Jena University Hospital

    STUDY DIRECTOR
  • Karolin Trautmann-Grill, Dr. med.

    Dresden Univeristy Hospital

    STUDY DIRECTOR

Central Study Contacts

Karolin Trautmann-Grill, Dr. med.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 23, 2021

First Posted

December 9, 2021

Study Start

November 29, 2021

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

There is no validated data sharing procedure at the university hospital Jena. But of course it is planned to share the results with scientific community and publish the data in a scientific journal.

Locations