This observational study enrolls patients who have received at least one infusion of octaplasLG®. OctaplasLG® will be administered standard of care and observation occurs during the treatment and 24 hours after the end of treatment. Characteristics of the use of octaplasLG®, tolerance criteria, and efficacy criteria will be collected.
Prospective, non-interventional, multicentre study meeting a post-marketing need. The data will be collected in all patients who have received at least one infusion of octaplasLG®. The duration of follow-up is limited to the duration of treatment with octaplasLG® plus 24 h of monitoring after cessation of treatment. Characteristics of the use of octaplasLG® (indication for the transfusion, degree of urgency, characteristics of plasma infusions, patient characteristics, number of iso-group and/or compatible units administered, tolerance criteria (adverse effects), and efficacy criteria (for patients with confirmed diagnosis of TTP--time to normalization of platelet count) will be collected.
Study Type
OBSERVATIONAL
Enrollment
263
Data will be collected in all patients who have received at least one infusion of octaplasLG®
CH Henri Duffaut
Avignon, France
Hôpital de La Cavale Blanche
Brest, France
Hôpital Louis Pradel
Bron, France
Indication for the transfusion of octaplasLG®
Indication for the transfusion of octaplasLG®
Time frame: From start of treatment to 24 hours following treatment with octaplasLG®
Degree of urgency - Ordering department of octaplasLG®
Degree of urgency - Ordering department of octaplasLG®
Time frame: From start of treatment to 24 hours following treatment with octaplasLG®
Characteristics of the plasma infusions performed (transfusion or PE, administration rate, volume, date)
Characteristics of the plasma infusions performed (transfusion or PE, administration rate, volume, date)
Time frame: From start of treatment to 24 hours following treatment with octaplasLG®
Patient characteristics (socio-demographic criteria, blood group, dominant pathology, co-morbidities including allergies, prior treatments)
Patient characteristics (socio-demographic criteria, blood group, dominant pathology, co-morbidities including allergies, prior treatments)
Time frame: From start of treatment to 24 hours following treatment with octaplasLG®
Number of iso-group and/or compatible units administered for octaplasLG®
Number of iso-group and/or compatible units administered for octaplasLG®
Time frame: From start of treatment to 24 hours following treatment with octaplasLG®
Tolerance of octaplasLG®: Adverse effects (with notion of Severity and Imputability, time to onset/start of infusion) associated with the plasma
Tolerance of octaplasLG®: Adverse effects (with notion of Severity and Imputability, time to onset/start of infusion) associated with the plasma including allergic immunological type (e.g. TRALI) and other events (infections, related to the PE procedure (e.g. case of transfusion-associated circulatory overload \[TACO\], citrate reaction, etc.).
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Infirmerie Protestante de Lyon
Caluire-et-Cuire, France
Hospices Civils de Lyon Hôpital Edouard Herriot
Lyon, France
Hôpital de la Conception
Marseille, France
APHP Hopital Pitié salpêtrière
Paris, France
APHP Hopital Cochin
Paris, France
CHU Hôpitaux de Rouen
Rouen, France
CHRU Hôpital Nord
Saint-Etienne, France
...and 4 more locations
Time frame: From start of treatment to 24 hours following treatment with octaplasLG®
Efficacy criteria in the treatment of TTP including time to normalisation of platelet count (time between first PE procedure and a confirmed platelet count > 150 x 109/L on at least 2 consecutive days)
Efficacy criteria in the treatment of TTP including time to normalisation of platelet count (time between first PE procedure and a confirmed platelet count \> 150 x 109/L on at least 2 consecutive days)
Time frame: From start of treatment to 24 hours following treatment with octaplasLG®