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Clinical Trials/NCT05634928
NCT05634928RecruitingNot Applicable

Construction of a Database for Thrombotic Microangiopathy

The First Affiliated Hospital of Soochow University1 site in 1 country500 target enrollmentStarted: December 1, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
500
Locations
1
Primary Endpoint
Number of participants with stroke
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Number of participants with stroke

Time Frame: 5 years from the time of entering the database.

Stroke was assessed with MRI imaging.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
The First Affiliated Hospital of Soochow University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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