PMID- 37236666 OWN - NLM STAT- MEDLINE DCOM- 20230529 LR - 20230602 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 13 IP - 5 DP - 2023 May 26 TI - Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery (EFISS): a study protocol of two-arm, randomised trial. PG - e071547 LID - 10.1136/bmjopen-2022-071547 [doi] LID - e071547 AB - INTRODUCTION: Fibrinogen is one of the essential coagulation factors. Preoperative lower plasma fibrinogen level has been associated with higher blood loss. Scoliosis surgery presents a challenge for the anaesthetic team, one of the reasons being blood loss and transfusion management. Recently, the prophylactic fibrinogen administration has been a debated topic in various indications. It has been described for example, in urological or cardiovascular surgery, as well as in paediatrics. This pilot study is focused on verifying the feasibility of potential large randomised trial and verifying the safety of prophylactic fibrinogen administration in paediatric scoliosis surgery. METHODS AND ANALYSIS: A total of 32 paediatric patients indicated for scoliosis surgery will be recruited. Participants will be randomised into study groups in a 1:1 allocation ratio. Patients in the intervention group will receive prophylactic single dose of fibrinogen, in addition to standard of care. Patients in the control group will receive standard of care without study medication prior to skin incision. The primary aim is to assess the safety of prophylactic fibrinogen administration during scoliosis surgery in children, the incidence of any adverse events (AEs) and reactions will be monitored during participation in the study. The secondary objective is to investigate the additional safety information, feasibility and efficacy of a prophylactic fibrinogen administration. The incidence of AEs and reactions according to selected adverse events of special interest will be monitored. All collected data will be subjected to statistical analysis according to a separate statistical analysis plan. ETHICS AND DISSEMINATION: This trial follows the applicable legislation and requirements for good clinical practice according to the International Conference on Harmonisation E6(R2). All essential trial documents were approved by the relevant ethics committee and national regulatory authority (State Institute for Drug Control) and their potential amendments will be submitted for approval. TRIAL REGISTRATION NUMBER: NCT05391412. CI - (c) Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Vrbica, Kamil AU - Vrbica K AD - Department of Anaesthesiology and Intensive Care Medicine, University Hospital Brno, Brno, Czech Republic. AD - Department of Anaesthesiology and Intensive Care Medicine, Masaryk University, Faculty of Medicine, Brno, Czech Republic. FAU - Hudec, Jan AU - Hudec J AUID- ORCID: 0000-0002-1781-2537 AD - Department of Anaesthesiology and Intensive Care Medicine, University Hospital Brno, Brno, Czech Republic hudeja@gmail.com. AD - Department of Anaesthesiology and Intensive Care Medicine, Masaryk University, Faculty of Medicine, Brno, Czech Republic. FAU - Hrdy, Ondrej AU - Hrdy O AD - Department of Anaesthesiology and Intensive Care Medicine, University Hospital Brno, Brno, Czech Republic. AD - Department of Anaesthesiology and Intensive Care Medicine, Masaryk University, Faculty of Medicine, Brno, Czech Republic. FAU - Galko, Michal AU - Galko M AD - Department of Orthopaedic Surgery, University Hospital Brno, Brno, Czech Republic. AD - Department of Orthopaedic Surgery, Masaryk University, Faculty of Medicine, Brno, Czech Republic. FAU - Horalkova, Hana AU - Horalkova H AD - Department of Anaesthesiology and Intensive Care Medicine, University Hospital Brno, Brno, Czech Republic. AD - Department of Anaesthesiology and Intensive Care Medicine, Masaryk University, Faculty of Medicine, Brno, Czech Republic. FAU - Demlova, Regina AU - Demlova R AD - Department of Pharmacology/CZECRIN, Masaryk University Faculty of Medicine, Brno, Czech Republic. FAU - Kubelova, Michaela AU - Kubelova M AUID- ORCID: 0000-0001-5928-0383 AD - Department of Pharmacology/CZECRIN, Masaryk University Faculty of Medicine, Brno, Czech Republic. FAU - Repko, Martin AU - Repko M AD - Department of Orthopaedic Surgery, University Hospital Brno, Brno, Czech Republic. AD - Department of Orthopaedic Surgery, Masaryk University, Faculty of Medicine, Brno, Czech Republic. FAU - Gal, Roman AU - Gal R AD - Department of Anaesthesiology and Intensive Care Medicine, University Hospital Brno, Brno, Czech Republic. AD - Department of Anaesthesiology and Intensive Care Medicine, Masaryk University, Faculty of Medicine, Brno, Czech Republic. LA - eng SI - ClinicalTrials.gov/NCT05391412 PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230526 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 RN - 9001-32-5 (Fibrinogen) RN - 0 (Hemostatics) SB - IM MH - Humans MH - Child MH - Fibrinogen/therapeutic use MH - *Scoliosis/surgery MH - Pilot Projects MH - *Hemostatics/therapeutic use MH - Hemorrhage/prevention & control MH - Treatment Outcome MH - Randomized Controlled Trials as Topic PMC - PMC10230982 OTO - NOTNLM OT - anaesthesia in orthopaedics OT - blood bank & transfusion medicine OT - orthopaedic & trauma surgery OT - paediatrics OT - scoliosis COIS- Competing interests: In the past 5 years, KV and RG have received honoraria for lecturing from CSL Behring. EDAT- 2023/05/27 09:42 MHDA- 2023/05/29 06:42 PMCR- 2023/05/26 CRDT- 2023/05/26 20:53 PHST- 2023/05/29 06:42 [medline] PHST- 2023/05/27 09:42 [pubmed] PHST- 2023/05/26 20:53 [entrez] PHST- 2023/05/26 00:00 [pmc-release] AID - bmjopen-2022-071547 [pii] AID - 10.1136/bmjopen-2022-071547 [doi] PST - epublish SO - BMJ Open. 2023 May 26;13(5):e071547. doi: 10.1136/bmjopen-2022-071547.