Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study

NCT05950750 | Recruiting

• 1 other identifier: eTTP-THD
• Study Type: observational
• Target: 960
• Locations: 1 country
• Sites: 1

Brief Summary

21 hematology centers in Turkey will participate in this noninterventional observational study. The recruitment target is 960 cases. Patients will be followed-up at least 1 year or to the end of the study according to the physicians' discretion, or withdrawal of consent. Recruitment period will be 36 months. Data will be collected via electronic case report form. Since the study cohort does not include only newly diagnosed patients, all aTTP patients will be included to the study, previous treatments and diagnosis information data could also be collected from hospital records. Patients recruitment duration: 3 years (36 months) Patients follow-up duration: 1 year (12 months)

Conditions

TTP - Thrombotic Thrombocytopenic Purpura

Keywords

TTP; THD

Outcome Measures

Primary Outcomes (2)

• Number of episodes

  Median number of episodes will be given

  Through study completion, an average of 4 years

• To describe treatment patterns among TTP patients

  All treatments received by patients will be expressed as percentages

  Through study completion, an average of 4 years

Secondary Outcomes (1)

• To describe demographic characteristics of TTP patients

  24 months

Study Arms (1)

All Patients

Non interventional observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with TTP and signed an informed written consent will be included into the study. Because of the non-interventional nature of the study, there is no predefined treatment protocol. The patients will be treated according to the routine practices of the centers. In observational drug studies, the drug to be administered in treatment should be prescribed and patient's treatment should be started prior to study inclusion decision is made as a principle. The participating physician will continue to treat the patients according to their routine practices. Not only newly diagnosed patients, all aTTP patients within participated centers will be recruited and 12 months follow-up data will be collected.

You may qualify if:

• Diagnosed as aTTP after 01.01.2015
• Patients with ADAMS13\<10%
• Thrombocytopenia (\<100.000)
• Coombs (-)
• Microangiopathic hemolytic amenia
• years and older

You may not qualify if:

• \- Patient who does not sign informed consent form

Sponsors & Collaborators

• Turkish Hematology Association: lead
• Sanofi: collaborator

Study Sites (1)

Baskent Universtiy Faculty of Medicine

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Karakus S, Bakanay SM, Kalayoglu Besisik S, Eskazan AE, Ayyildiz O, Gurkan E, Salim O, Karakus V, Guler N, Keklik M, Ozcebe OI, Ozkalemkas F, Ozkocaman V, Yilmaz U, Dadin S, Ucar MA, Sonmez M, Karakus A, Atas U, Koc LZ, Gunduz E, Kabukcu Hacioglu S, Unver Koluman B, Ozet G, Guney T, Fidan K, Karaagac Akyol T, Kikili CI, Demirkan F, Yavasoglu I, Dagtas S, Kestane M, Uskudar Teke H, Kocak Toprak S, Karatas A, Yagci M, Ozatli D, Ozkurt ZN, Ilhan O, Ar MC. Clinical Manifestations, Treatment Characteristics, and Clinical Outcomes in Patients with Immune Thrombotic Thrombocytopenic Purpura (iTTP) in a Real-World Setting: An Interim Analysis of the Turkish iTTP Registry. Turk J Haematol. 2025 Aug 29;42(3):203-212. doi: 10.4274/tjh.galenos.2025.2025.0134. Epub 2025 Jul 23.

  PMID: 40699136 DERIVED

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

• ilker kurkcu

  Sentez-CRO

  STUDY DIRECTOR

Central Study Contacts

ilker kurkcu

CONTACT

+905326354515; ilker.kurkcu@sentez-cro.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: July 18, 2023
• Study Start: December 21, 2022
• Primary Completion: December 21, 2023
• Study Completion (Estimated): December 21, 2026
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)