Construction of a Database for TMA
Sponsor
The First Affiliated Hospital of Soochow University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05634928
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 Dec 1, 2022, to Nov 31, 2027. The observation indexes of the study include the basic information of patients' age and gender and the clinical-related data of thrombotic microangiopathy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
500 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Construction of a Database for Thrombotic Microangiopathy
Anticipated Study Start Date
:
Dec 1, 2022
Anticipated Primary Completion Date
:
Nov 30, 2027
Anticipated Study Completion Date
:
Nov 30, 2028
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| TMA TMA 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
Inclusion Criteria:
- The patient has elevated lactate dehydrogenase to more than twice the baseline value, platelets less than 20 or decreased by more than 50% within 24 hours, and more than 2% of schistocytes visible on a peripheral blood smear. Alternatively, pathological sections show extensive micro thrombosis.
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:
NCT05634928
Other Study ID Numbers:
- SOOCHOW-HY-2022-13
First Posted:
Dec 2, 2022
Last Update Posted:
Dec 2, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: