NCT05571774

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
30mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Oct 2022Oct 2028

First Submitted

Initial submission to the registry

September 27, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

October 20, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2028

Last Updated

October 7, 2022

Status Verified

September 1, 2022

Enrollment Period

5 years

First QC Date

September 27, 2022

Last Update Submit

October 5, 2022

Conditions

TTP - Thrombotic Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

  • Number of participants with stroke

    Stroke was assessed with MRI imaging.

    5 years from the time of entering the database.

Study Arms (1)

TTP

TTP patients

Other: collection data

Interventions

collection dataOTHER

collection data

TTP

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • \- Subjects diagnosed with severe ADAMTS13 deficiency, defined as ADAMTS13 activity \<10%, documented in the patient's medical history or at screening.

You may not qualify if:

  • \- The investigator considers the subject unable or unwilling to cooperate with the study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the first affiliated hospital of Soochow university

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombotic Thrombocytopenic

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaThrombophiliaHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Yue Han, Ph.D

CONTACT

+86 18913091817hanyue@suda.edu.cn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 7, 2022

Study Start

October 20, 2022

Primary Completion (Estimated)

October 20, 2027

Study Completion (Estimated)

October 20, 2028

Last Updated

October 7, 2022

Record last verified: 2022-09

Locations

CN(1)