Construction of a Database for TTP

TTP - Thrombotic Thrombocytopenic Purpura Clinical Trial

Official title:

Construction of a Database for Thrombotic Thrombocytopenic Purpura

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05571774
• Other study ID #: SOOCHOW-HY-2022-12
• Status: Recruiting
• Start date: October 20, 2022
• Est. completion date: October 20, 2028

Study information

• Verified date: September 2022
• Source: The First Affiliated Hospital of Soochow University
• Contact: Yue Han, Ph.D
• Phone: +86 18913091817
• Email: hanyue[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Information about patients was collected by reviewing the Hitech case system and telephone and outpatient follow-up, and the case database was constructed by Epidata software. The sample size is expected to be 200 cases, the participating hospital is the First Affiliated Hospital of Soochow University, and the study time frame is from Oct 20, 2022, to Oct 20, 2027. The observation indexes of the study include the basic information of patients' age and gender and the clinical related data of thrombotic thrombocytopenic purpura.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 20, 2028
• Est. primary completion date: October 20, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subjects diagnosed with severe ADAMTS13 deficiency, defined as ADAMTS13 activity <10%, documented in the patient's medical history or at screening.

Exclusion Criteria:

• The investigator considers the subject unable or unwilling to cooperate with the study procedures.

Related Conditions & MeSH terms

• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombotic Thrombocytopenic
• TTP - Thrombotic Thrombocytopenic Purpura

Intervention

Other:
• collection data
collection data

Locations

Country	Name	City	State
China	the first affiliated hospital of Soochow university	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with stroke	Stroke was assessed with MRI imaging.	5 years from the time of entering the database.