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

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Jun 13, 2017

Keywords

ClinConnect Summary

This clinical trial is focused on understanding the long-term effects of a condition called Thrombotic Thrombocytopenic Purpura (TTP) on blood vessels. The study aims to follow patients who have recently experienced their first episode of TTP and are now in remission, meaning their symptoms have improved and their blood tests have returned to normal for at least 30 days. Researchers want to see how these patients’ blood vessels are affected over a period of 12 months after their initial recovery.

To participate in this trial, individuals need to be at least 18 years old and have had a recent diagnosis of their first TTP episode that was treated successfully. They should not have any other serious medical conditions or be taking certain medications that could interfere with the study. Participants can expect regular follow-ups and scans to monitor their health, which will help researchers gather important information about TTP and its long-term effects. This study is currently recruiting participants, and anyone interested should consult their healthcare provider for more details.

Gender

ALL

Eligibility criteria

• 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.