Detailed Information on Publication Record
2023
Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery (EFISS): a study protocol of two-arm, randomised trial
VRBICA, Kamil, Jan HUDEC, Ondřej HRDÝ, Michal GALKO, Hana HORALKOVA et. al.Basic information
Original name
Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery (EFISS): a study protocol of two-arm, randomised trial
Authors
VRBICA, Kamil (203 Czech Republic, belonging to the institution), Jan HUDEC (203 Czech Republic, guarantor, belonging to the institution), Ondřej HRDÝ (203 Czech Republic, belonging to the institution), Michal GALKO (703 Slovakia, belonging to the institution), Hana HORALKOVA (203 Czech Republic), Regina DEMLOVÁ (203 Czech Republic, belonging to the institution), Michaela KUBELOVÁ (203 Czech Republic, belonging to the institution), Martin REPKO (203 Czech Republic, belonging to the institution) and Roman GÁL (203 Czech Republic, belonging to the institution)
Edition
BMJ Open, London, BMJ Publishing Group, 2023, 2044-6055
Other information
Language
English
Type of outcome
Článek v odborném periodiku
Field of Study
30223 Anaesthesiology
Country of publisher
United Kingdom of Great Britain and Northern Ireland
Confidentiality degree
není předmětem státního či obchodního tajemství
References:
Impact factor
Impact factor: 2.900 in 2022
RIV identification code
RIV/00216224:14110/23:00131159
Organization unit
Faculty of Medicine
UT WoS
001001066100033
Keywords in English
scoliosis; paediatrics; orthopaedic & trauma surgery; anaesthesia in orthopaedics; blood bank & transfusion medicine
Tags
International impact, Reviewed
Změněno: 25/1/2024 12:07, Mgr. Tereza Miškechová
Abstract
V originále
IntroductionFibrinogen 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 analysisA 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 disseminationThis 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.
Links
| MUNI/A/1336/2022, interní kód MU |
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| 90249, large research infrastructures |
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