To assess and evaluate the safety of octaplas™ in comparison to standard plasma product (e.g., fresh frozen plasma (FFP) and other approved plasma products used within 24 hours of thawing) used in the treatment of TTP, in patients undergoing Therapeutic Plasma Exchange, with a special emphasis on the occurrence of thromboembolic events (TEEs).
Study Type
OBSERVATIONAL
Enrollment
1
Octoplas infusion solution for IV administration
Plasma given as replacement fluid
Octapharma Study Site
Manhasset, New York, United States
Octapharma Study Site
Rochester, New York, United States
The incidence of TEEs in patients receiving octaplas™ will be compared with the incidence rate in patients receiving plasma issued according to institutional standard of care.
Time frame: Up to 28 days followed by a 24 hour follow-up
Incidence of Citrate reactions during TPE based on clinical judgment of physician.
Time frame: Up to 28 days followed by a 24 hour follow-up
Incidence of Plasma-associated adverse reactions including Transfusion-Associated Circulatory Overload (TACO),
Time frame: Up to 28 days followed by a 24 hour follow-up
Incidence of Transfusion-Related Acute Lung Injury (TRALI)
Time frame: Up to 28 days followed by a 24 hour follow-up
Incidence of febrile reactions
Time frame: Up to 28 days followed by a 24 hour follow-up
Measurement of Safety laboratory parameters - International Normalized Ratio (INR)
Time frame: Up to 28 days followed by a 24 hour follow-up
Measurement of Prothrombin Time (PT)/Partial Thromboplastin Time (PTT).
Time frame: Up to 28 days followed by a 24 hour follow-up
Determination of overall clinical response (rating scale that takes into account platelet count, LDH levels, creatinine and neurological status).
Time frame: Up to 28 days followed by a 24 hour follow-up
measurement of Platelet count
Time frame: Up to 28 days followed by a 24 hour follow-up
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measurement of hemoglobin
Time frame: Up to 28 days followed by a 24 hour follow-up
measurement of hematocrit
Time frame: Up to 28 days followed by a 24 hour follow-up
measurement of LDH.
Time frame: Up to 28 days followed by a 24 hour follow-up