Construction of a Database for TTP
Sponsor
The First Affiliated Hospital of Soochow University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05571774
Collaborator
(none)
500
1
72
6.9
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
500 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Construction of a Database for Thrombotic Thrombocytopenic Purpura
Anticipated Study Start Date
:
Oct 20, 2022
Anticipated Primary Completion Date
:
Oct 20, 2027
Anticipated Study Completion Date
:
Oct 20, 2028
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| TTP TTP patients |
Other: collection data
collection data
|
Outcome Measures
Primary Outcome Measures
- Number of participants with stroke [5 years from the time of entering the database.]
Stroke was assessed with MRI imaging.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the first affiliated hospital of Soochow university | Suzhou | Jiangsu | China | 215006 |
Sponsors and Collaborators
- The First Affiliated Hospital of Soochow University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier:
NCT05571774
Other Study ID Numbers:
- SOOCHOW-HY-2022-12
First Posted:
Oct 7, 2022
Last Update Posted:
Oct 7, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: