Prior to the use of plasma products, thrombotic thrombocytopenic purpura (TTP) was usually a fatal condition. During plasma exchange therapy, patients need transfusion plasma that is blood group specific. Transfusing a patient with an incorrect blood group may have fatal consequences. Uniplas is a universally applicable human plasma, which can be administered irrespective of the patient's blood group. This study will test the safety and efficacy of Uniplas in comparison to cryosupernatant plasma in treatment of patients with TTP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
8
Uniplas will be provided frozen in sterile plastic bags.
Cryosupernatant plasma will be provided frozen in sterile plastic bags.
Contact Octapharma for Facility Details
Centreville, Virginia, United States
Change from baseline in (log) platelet count 1 month after treatment initiation
Log platelet count was reported in units, where 1 unit = 10\^9/L platelets.
Time frame: Baseline to Month 1
Percentage of participants who died at 1 and 3 months after treatment initiation
Time frame: Baseline to Month 3
Percentage of participants with a complete response (CR), a partial response (PR), a non-response (NR), or a transient response (TR) after the first treatment cycle and at 1 month
A CR was defined as a platelet count \> 150 x 10\^9/L on 2 consecutive days, and a decrease of lactate dehydrogenase (LDH) to within 1.25 times the upper limit of the normal range, and a resolution of previous neurological symptoms, and no new neurological symptoms. A PR was defined as at least a 2-fold increase in platelet count from baseline which is \> 50 x 10\^9/L. A NR was defined as a \< 2-fold increase in platelet count, or a platelet count \< 50 x 10\^9/L, or severe red blood cell (RBC) fragmentation, or the development of new neurological symptoms, or no improvement in neurological status as defined by the level of consciousness. A TR was defined as achievement of a complete or partial response which then deteriorated, defined by a 50% decrease in peak platelet count, or neurological deterioration, or a 100% increase in nadir LDH level, or severe RBC fragmentation.
Time frame: Baseline to Month 1
Total volume of plasma exchange fluid administered during treatment cycles up to 1 month
Time frame: Baseline to Month 1
Time to reach maximum platelet count
Platelet count was reported in units, where 1 unit = 10\^9/L platelets.
Time frame: Baseline to the end of the study (up to 7 months)
Best clinical response (complete response [CR], partial response [PR], non-response [NR], transient response [TR]) during the study
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The percentage of participants with a CR, PR, NR, or TR, as their best clinical response during the study, is reported. A CR was defined as a platelet count \> 150 x 10\^9/L on 2 consecutive days, and a decrease of lactate dehydrogenase (LDH) to within 1.25 times the upper limit of the normal range, and a resolution of previous neurological symptoms, and no new neurological symptoms. A PR was defined as at least a 2-fold increase in platelet count from baseline which is \> 50 x 10\^9/L. A NR was defined as a \< 2-fold increase in platelet count, or a platelet count \< 50 x 10\^9/L, or severe red blood cell (RBC) fragmentation, or the development of new neurological symptoms, or no improvement in neurological status as defined by the level of consciousness. A TR was defined as achievement of a complete or partial response which then deteriorated, defined by a 50% decrease in peak platelet count, or neurological deterioration, or a 100% increase in nadir LDH level, or severe RBC fragmentation.
Time frame: Baseline to the end of the study (up to 7 months)