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A Prospective Study on the Long-Term Vascular Burden in Thrombotic Thrombocytopenic Purpura Patients | Clinical Trials | Clareo Health

RECRUITING

A Prospective Study on the Long-Term Vascular Burden in Thrombotic Thrombocytopenic Purpura Patients

NCT03187652•London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

View on ClinicalTrials.gov

Summary

A prospective cohort study of thrombotic thrombocytopenic purpura and atypical hemolytic uremic syndrome patients who have presented with their acute episode and are in remission within the last 30 days. They will be followed for 12 months from the time of their initial scan, followed by a long-term follow up study.

Detailed Description

The investigators will conduct a prospective cohort study at the London Health Sciences Centre, Ontario, Canada. The investigators will identify 15-30 idiopathic thrombotic thrombocytopenic purpura and atypical hemolytic uremic syndrome patients who are in remission within the last 30 days. They will be followed for 12 months from the time of their remission. Study procedures include routine laboratory monitoring, biomarker assessments, cardiovascular and neurocognitive functional assessments, and non-invasive imaging studies. The long-term follow-up thrombotic thrombocytopenic purpura and atypical hemolytic uremic syndrome study will help to assess the mechanisms of vascular injuries, evaluate cardiovascular and cerebrovascular monitoring tools, and generate novel ideas to prevent further vascular injuries.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults (=18 years) with a recent diagnosis of their first episode of idiopathic TTP, who have been treated with plasma exchange with or without other therapies, and who are in remission. Remission is defined as the normalization of platelet counts and lactate dehydrogenase levels with no clinical signs or symptoms of microvascular injury for more than 30 days. The patients will be included in the study within 30 days of remission of their symptoms. The patients will all meet the following diagnostic criteria for idiopathic TTP: (1) thrombocytopenia with platelet count \<150 x 109 /L, (2) microangiopathic hemolytic anaemia (presence of red blood cell fragmentation by peripheral blood smear), (3) elevation of lactate dehydrogenase (LDH)\> 1.25 X of the upper limit of normal, and (4) ADAMTS13 Activity \< 10%

Exclusion Criteria

•Patients will be excluded if they have diagnoses of typical HUS (diarrhea-associated HUS), atypical HUS, and disseminated intravascular coagulation, have abnormal international normalized ratio at the time of presentation, have diagnoses of malignant hypertension at the time of presentation, are on the following drugs within 90 days prior to their presentation: ticlopidine, clopidogrel, mitomycin C, gemcitabine, cyclosporine, and quinine, have a history of hematopoietic stem cell transplantations prior to their presentation, have a history and/or diagnosis of vasculitis, systemic lupus erythematosus, scleroderma, rheumatoid arthritis, antiphospholipid antibody syndrome, or HIV/AIDS, have a history of solid organ malignancy within 5 years prior to presentation, i.e. lung, breast, gastric, colon, pancreatic, prostate, or liver, are pregnant at the time of presentation, have severe bronchospasm, unstable angina, and severe ischemic heart disease, have advanced kidney failure (estimated Glomerular Filtration Rate \< 30 mL/min/1.73m2), and have history of allergic reaction to contrast dye.

Locations (1)

London Health Sciences Centre

London, Ontario, Canada

Key Dates

Start Date

January 1, 2017

Primary Completion Date

January 1, 2026

Completion Date

January 1, 2026

Last Updated

March 13, 2024

Enrollment

ESTIMATED participants

Conditions

Thrombotic Thrombocytopenic Purpura

Interventions

CT Perfusion Study

DIAGNOSTIC_TEST

Echocardiogram

DIAGNOSTIC_TEST

neuro-cognitive assessment

DIAGNOSTIC_TEST

MRI

DIAGNOSTIC_TEST

Contacts

Huang

CONTACT

519-685-8500 shuang45@uwo.ca

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TERMINATEDPHASE2

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WITHDRAWNPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Prospective Study on the Long-Term Vascular Burden in Thrombotic Thrombocytopenic Purpura Patients

Inclusion Criteria

Exclusion Criteria

Turkey Thrombotic Thrombocytopenic Purpura Disease Registry: National Multicenter Study

Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP)

SABRE: A Single-arm Prospective Study Measuring Safety and Tolerability of SARS-CoV-2 Neutralising Antibodies in High-risk Populations

Phase III Trial With Caplacizumab in Patients With Acquired Thrombotic Thrombocytopenic Purpura

Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)

A Retrospective, Observational Study on the Response to Caplacizumab Treatment in aTTP Patients: the Italian Experience (ROSCAPLI)