Thrombotic Thrombocytopenic Purpura (TTP)
Conditions
Keywords
bleeding disorder, universal plasma, plasma, plasma exchange
Brief summary
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.
Interventions
BIOLOGICALUniplas
Uniplas will be provided frozen in sterile plastic bags.
BIOLOGICALCryosupernatant plasma
Cryosupernatant plasma will be provided frozen in sterile plastic bags.
Sponsors
Octapharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age and above. * Definite diagnosis of acute thrombotic thrombocytopenic purpura (TTP). * Thrombocytopenia. * Diagnostic signs of microangiopathic hemolytic anemia.
Exclusion criteria
* Congenital thrombotic microangiopathies. * Alternative secondary cause for microangiopathy. * Co-morbid illness limiting life expectancy to less than 3 months independent of TTP. * Patients known to be HIV positive. * Patients known to have lupus. * Refusal to accept blood products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in (log) platelet count 1 month after treatment initiation | Baseline to Month 1 | Log platelet count was reported in units, where 1 unit = 10\^9/L platelets. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who died at 1 and 3 months after treatment initiation | 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 | Baseline to Month 1 | 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. |
| Total volume of plasma exchange fluid administered during treatment cycles up to 1 month | Baseline to Month 1 | — |
| Time to reach maximum platelet count | Baseline to the end of the study (up to 7 months) | Platelet count was reported in units, where 1 unit = 10\^9/L platelets. |
| Best clinical response (complete response [CR], partial response [PR], non-response [NR], transient response [TR]) during the study | Baseline to the end of the study (up to 7 months) | 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. |
Countries
United States
Outcome results
None listed