ClinicalTrials.gov record NCT05571774

Construction of a Database for TTP

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Construction of a Database for Thrombotic Thrombocytopenic Purpura

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Oct 7, 2022, about 4 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study collects clinical information on people diagnosed with thrombotic thrombocytopenic purpura (TTP). Data are gathered from medical records, telephone and outpatient follow-up, and entered into a case database using Epidata. The study records basic demographics and clinical details and tracks outcomes such as stroke over time.

What it is studying. The study is building a database of clinical and follow-up information for people with TTP to describe patient characteristics and record outcomes (for example, number of participants who experience stroke as assessed by MRI within five years of entering the database).

What the researchers hope to learn. To create a structured database of clinical and demographic information on people with TTP and to document outcomes such as stroke incidence over five years; to provide a resource for future research on TTP.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • collection data

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Researchers will collect clinical information into a database by reviewing hospital case records and by telephone or outpatient follow-up. The study will record basic information (for example, age and sex) and clinical data related to TTP. Stroke is listed as an outcome and will be assessed with MRI imaging over five years from database entry (the record does not state whether MRIs are newly performed for the study or taken from existing records).

How the study is structured. Observational, case-only, cross-sectional study. No treatments are assigned. Researchers review medical records and collect follow-up information (telephone or outpatient) to enter patients' clinical data into a database.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on thrombotic thrombocytopenic purpura

Important dates

Study start
Oct 20, 2022 (estimated)
Primary completion
Oct 20, 2027 (estimated)
Study completion
Oct 20, 2028 (estimated)
Target enrollment
500 participants (estimated)
Last updated on registry
Oct 7, 2022
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
The First Affiliated Hospital of Soochow University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
time frame
The period over which an outcome is measured, for example 'at 12 weeks'. It is not necessarily the total length of the study.
at screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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