- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05571774
Construction of a Database for TTP
October 5, 2022 updated by: The First Affiliated Hospital of Soochow University
Construction of a Database for Thrombotic Thrombocytopenic Purpura
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yue Han, Ph.D
- Phone Number: +86 18913091817
- Email: hanyue@suda.edu.cn
Study Locations
-
-
Jiangsu
-
Suzhou, Jiangsu, China, 215006
- Recruiting
- The First Affiliated Hospital of Soochow University
-
Contact:
- Xiang Zhang, Ph.D
- Phone Number: +86 18913091817
- Email: zhangxiang@suda.edu.cn
-
Principal Investigator:
- Yue Han, Ph.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
A total of 500 eligible TTP patients are to be collected for this project.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
TTP
TTP patients
|
collection data
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with stroke
Time Frame: 5 years from the time of entering the database.
|
Stroke was assessed with MRI imaging.
|
5 years from the time of entering the database.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 20, 2022
Primary Completion (Anticipated)
October 20, 2027
Study Completion (Anticipated)
October 20, 2028
Study Registration Dates
First Submitted
September 27, 2022
First Submitted That Met QC Criteria
October 5, 2022
First Posted (Actual)
October 7, 2022
Study Record Updates
Last Update Posted (Actual)
October 7, 2022
Last Update Submitted That Met QC Criteria
October 5, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOOCHOW-HY-2022-12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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