Thrombotic Thrombocytopenic PurpuraTTPNCT03187652
A Prospective Study on the Long-Term Vascular Burden in Thrombotic Thrombocytopenic Purpura Patients
An observational study of Thrombotic Thrombocytopenic Purpura, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombotic Thrombocytopenic Purpura
- What is being tested?
- CT Perfusion Study, Echocardiogram and neuro-cognitive assessment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2017to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Idiopathic TTP
Who may be able to join
- 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%
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5W9
Huang, 519-685-8066, shuang45@uwo.ca
About this study
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.
Read the 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.
- Conditions
- Thrombotic Thrombocytopenic Purpura
- Being tested
- CT Perfusion Study, Echocardiogram, neuro-cognitive assessment, MRI
- Medical subject headings
- Purpura, Thrombotic Thrombocytopenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT Perfusion StudyDiagnostic test
Brain and cardiac CT perfusion scan
EchocardiogramDiagnostic test
Speckle tracking Echocardiography
neuro-cognitive assessmentDiagnostic test
Cambridge Brain Sciences neuro-cognitive assessment
MRIDiagnostic test
MRI to assess white matter changes
What is being measured
The primary outcome is the main question the study is designed to answer.
vascular events affecting the brain and heart
The investigators will report the proportion of patients who have functional and/or structural vascular events affecting the brain and heart, after the first acute idiopathic TTP events
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start1 Jan 2017
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thrombotic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huang, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187652
- Sponsor's protocol ID
- 108273
- Acronym
- TTP
- Status last verified
- Mar 2024
- First submitted
- 13 Jun 2017
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hannan F, Thiessen JD, Patriquin CJ, Pavenski K, Tristao L, Lee TY, Mendes D, Theberge J, Mandzia JL, Al-Jaishi M, Gallo KL, Huang SS. Neurological Impact of Caplacizumab in Refractory iTTP Survivors: A Comparative Study of Blood-Brain-Barrier Integrity and Cognitive Outcomes. Arterioscler Thromb Vasc Biol. 2026 Jul;46(7):e324382. doi: 10.1161/ATVBAHA.126.324382. Epub 2026 May 7.
PubMed 42093640Hannan F, Hamilton J, Patriquin CJ, Pavenski K, Jurkiewicz MT, Tristao L, Owen AM, Kosalka PK, Deoni SCL, Theberge J, Mandzia J, Huang SHS, Thiessen JD. Cognitive decline in thrombotic thrombocytopenic purpura survivors: The role of white matter health as assessed by MRI. Br J Haematol. 2024 Mar;204(3):1005-1016. doi: 10.1111/bjh.19246. Epub 2023 Dec 11.
PubMed 38083818
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Long-Term Vascular Burden in Thrombotic Thrombocytopenic Purpura Patients
- ClinicalTrials.gov ID
- NCT03187652
- Acronym / sponsor ID
- TTP / 108273
- Conditions
- Thrombotic Thrombocytopenic Purpura
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Idiopathic TTP
Key inclusion criteria (1 listed)
- 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%
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT Perfusion StudyBrain and cardiac CT perfusion scan | Diagnostic test | – |
| EchocardiogramSpeckle tracking Echocardiography | Diagnostic test | – |
| neuro-cognitive assessmentCambridge Brain Sciences neuro-cognitive assessment | Diagnostic test | – |
| MRIMRI to assess white matter changes | Diagnostic test | – |
Primary outcome
vascular events affecting the brain and heart
Time frame: 0-12 months
The investigators will report the proportion of patients who have functional and/or structural vascular events affecting the brain and heart, after the first acute idiopathic TTP events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 42093640Hannan F, Thiessen JD, Patriquin CJ, Pavenski K, Tristao L, Lee TY, Mendes D, Theberge J, Mandzia JL, Al-Jaishi M, Gallo KL, Huang SS. Neurological Impact of Caplacizumab in Refractory iTTP Survivors: A Comparative Study of Blood-Brain-Barrier Integrity and Cognitive Outcomes. Arterioscler Thromb Vasc Biol. 2026 Jul;46(7):e324382. doi: 10.1161/ATVBAHA.126.324382. Epub 2026 May 7.
- Derived from this study: PubMed 38083818Hannan F, Hamilton J, Patriquin CJ, Pavenski K, Jurkiewicz MT, Tristao L, Owen AM, Kosalka PK, Deoni SCL, Theberge J, Mandzia J, Huang SHS, Thiessen JD. Cognitive decline in thrombotic thrombocytopenic purpura survivors: The role of white matter health as assessed by MRI. Br J Haematol. 2024 Mar;204(3):1005-1016. doi: 10.1111/bjh.19246. Epub 2023 Dec 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huang principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombotic Thrombocytopenic Purpura, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huang (519-685-8500 ext. 58066, shuang45@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vascular events affecting the brain and heart (time frame: 0-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03187652, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.