Safety and Efficacy Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)
| Status: | Terminated |
|---|---|
| Conditions: | Hematology, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2007 |
| End Date: | February 2008 |
A Blinded Non-inferiority Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)
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.
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.
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.
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