Publication details

ZPRÁVA O ŘÁDNÉM UKONČENÍ KLINICKÉHO HODNOCENÍ EFISS

Title in English REPORT ON THE PROPER COMPLETION OF THE EFISS CLINICAL EVALUATION
Authors

DEMLOVÁ Regina KUBELOVÁ Michaela

Year of publication 2023
MU Faculty or unit

Faculty of Medicine

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.

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