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RecruitingNCT05571774Updated Oct 7, 2022

Construction of a Database for TTP

An observational study in TTP - Thrombotic Thrombocytopenic Purpura, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2022-10-07.

Sponsored by The First Affiliated Hospital of Soochow University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
500
Sex
All
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Study 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.

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Conditions studied

  • TTP - Thrombotic Thrombocytopenic Purpura
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In context

Purpura

263 studies on the registry are indexed under Purpura; 27 are open to participants now.

This study's planned enrollment of 500 is above the median of 150 across 74 observational studies indexed under Purpura.

Browse Purpura studies →

Lead sponsor

The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

A total of 500 eligible TTP patients are to be collected for this project.

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

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • TTP

    TTP patients

    Other: collection data

Interventions

  • Othercollection data

    collection data

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What researchers measure

Primary outcomes

  1. Number of participants with stroke

    Stroke was assessed with MRI imaging.

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

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Study locations

1 of 1 sites recruiting
  • the first affiliated hospital of Soochow university
    Suzhou, Jiangsu 215006, China
    • Xiang Zhang, Ph.D · Contact · zhangxiang@suda.edu.cn · +86 18913091817
    • Yue Han, Ph.D · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05571774
Lead sponsor
The First Affiliated Hospital of Soochow University
Responsible party
Sponsor
First posted
Oct 7, 2022
Start date
Oct 20, 2022 (estimated)
Primary completion
Oct 20, 2027 (estimated)
Completion
Oct 20, 2028 (estimated)
Last update
Oct 7, 2022

Study contacts

Yue Han, Ph.D
Contact
hanyue@suda.edu.cn
+86 18913091817

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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