Status:
WITHDRAWN
The Plasma Large-Volume Exchange RCT
Lead Sponsor:
London Health Sciences Centre
Conditions:
Purpura, Thrombotic Thrombocytopenic
Hemolytic Uremic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Thrombotic thrombocytopenia purpura / hemolytic uremic syndrome (TTP/HUS) is a rare, life-threatening disorder. TTP/HUS causes multiple blood clots to form, which prevents blood from reaching the brai...
Detailed Description
Background: Thrombotic thrombocytopenia purpura / haemolytic uremic syndrome (TTP/HUS) is a rare blood disorder with a high mortality rate of \>95% when left untreated. In 1991, researchers discovered...
Eligibility Criteria
Inclusion
- Age \> 18 year-old
- First presentation of TTP/HUS
- Meet all of the following diagnostic criteria:
- Platelet count \< 150 x 109 /L
- Microangiopathic haemolytic anaemia (blood film with presence of red blood cell fragmentation)
- LDH \> 1.25 X the upper limits of normal
- No alternative diagnosis
Exclusion
- Secondary TTP/HUS
- Relapsing TTP/HUS
- Hypersensitivity to blood product
- Patient has received 2 or more plasma exchange treatment since symptom started over the last 1 week
- Received medication, including cyclosporine, cyclophosphamide, rituximab for treatment of TTP/HUS
- Other causes of thrombocytopenia than TTP/HUS
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01433003
Start Date
April 1 2012
End Date
March 1 2015
Last Update
April 17 2013
Active Locations (1)
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1
Central Facility
London, Ontario, Canada, N6A 4G5