NCT05634928

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.

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
31mo left

Started Dec 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 Progress57%
Dec 2022Nov 2028

First Submitted

Initial submission to the registry

November 22, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

5 years

First QC Date

November 22, 2022

Last Update Submit

November 22, 2022

Conditions

Thrombotic Microangiopathies

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)

TMA

TMA patients

Other: collection data

Interventions

collection dataOTHER

collection data

TMA

Eligibility Criteria

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

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

You may qualify if:

  • 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.

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

Thrombotic Microangiopathies

Interventions

Data Collection

Condition Hierarchy (Ancestors)

ThrombocytopeniaBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

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, PhD

CONTACT

+86 18913091817hanyue@suda.edu.cn

Study Design

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

Study Record Dates

First Submitted

November 22, 2022

First Posted

December 2, 2022

Study Start

December 1, 2022

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2028

Last Updated

December 2, 2022

Record last verified: 2022-11

Locations

CN(1)