Publication details
ZPRÁVA O ŘÁDNÉM UKONČENÍ KLINICKÉHO HODNOCENÍ EFISS
| Title in English | REPORT ON THE PROPER COMPLETION OF THE EFISS CLINICAL EVALUATION |
|---|---|
| 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) aimed 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. A total of 32 patients were randomized (in a 1:1 ration) to the study arm with prophylactic administration of Haemocomplettan P (n=16) and to the study arm with standard care, the study was conducted in a double-blind mode. The report on trial termination summarizes the course of the study including basic safety data. Key words: EFISS, fibrinogen, scoliosis surgery, pediatric population, the report on trial termination. |