Zpráva o průběhu klinického hodnocení EFISS
| Title in English | EFISS Clinical Trial Annual Report |
|---|---|
| Authors | |
| Year of publication | 2023 |
| MU Faculty or unit | |
| Web | EFISS |
| Description | The pilot study "Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery: A randomized pilot study (EFISS trial)" (EudraCT No. 2021-005493-25) aims to verify the feasibility of a subsequent large randomized study focused on the safety of prophylactic fibrinogen administration during spinal scoliosis surgery in the pediatric population. In the first phase, a total of 32 patients will be randomized (in a 1:1 ratio) to the study arm with prophylactic administration of Haemocomplettan P (n=16) and to the study arm with standard of care, the study is double-blinded. The annual report summarizes the progress of the study in the first year of its duration, including safety data. |