Plasma transfusion in normal clinical practice Injury, Occupational Diseases, Poisoning Complications following infusion, transfusion and therapeutic injection
Conditions
Interventions
Before the first treatment with Octaplas® or Octaplas® LG, the physician will record the available baseline characteristics such as gender, date of birth, weight, blood group, diagnosis, and indicatio
Sponsors
Octapharma GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of any age who require a transfusion with Octaplas®/Octaplas® LG are eligible for study enrolment.
Exclusion criteria
Exclusion criteria: 1. Known relative contraindications such as latent or apparent cardial decompensation, hypervolaemia, hyperhydration, lung oedema and selective serum IgA deficiency 2. Known absolute contraindications such as hypersensitive against plasma proteins and antibodies against IgA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To observe the usage of the current product Octaplas® and the product with an additional chromatography step Octaplas® LG under normal clinical conditions to ascertain if there are any differences in patients outcomes with respect to effectiveness and tolerability. The effectiveness of Octaplas® and Octaplas® LG will be an objective assessment by the physician based on clinical or laboratory parameters relevant for the indication of whether the use of the product was successful or not. The tolerability will be evaluated on the basis of the number, nature, type and severity of adverse drug reactions (ADR). At the end of the study methods of descriptive statistics will be used to compare the effectiveness and tolerability of Octaplas® and Octaplas® LG. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures. | — |
Countries
Germany
Outcome results
None listed