Effect of Prophylactic Fibrinogen Concentrate In Scoliosis
Surgery (EFISS): a study protocol of two-arm, randomised trial

J 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.

Základní údaje

Originální název

Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery (EFISS): a study protocol of two-arm, randomised trial

Autoři

VRBICA, Kamil (203 Česká republika, domácí), Jan HUDEC (203 Česká republika, garant, domácí), Ondřej HRDÝ (203 Česká republika, domácí), Michal GALKO (703 Slovensko, domácí), Hana HORALKOVA (203 Česká republika), Regina DEMLOVÁ (203 Česká republika, domácí), Michaela KUBELOVÁ (203 Česká republika, domácí), Martin REPKO (203 Česká republika, domácí) a Roman GÁL (203 Česká republika, domácí)

Vydání

BMJ Open, London, BMJ Publishing Group, 2023, 2044-6055

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30223 Anaesthesiology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 2.900 v roce 2022

Kód RIV

RIV/00216224:14110/23:00131159

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1136/bmjopen-2022-071547

UT WoS

001001066100033

Klíčová slova anglicky

scoliosis; paediatrics; orthopaedic & trauma surgery; anaesthesia in orthopaedics; blood bank & transfusion medicine

Štítky

14110217, 14110233, 14110516, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 25. 1. 2024 12:07, Mgr. Tereza Miškechová

Anotace

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.

Návaznosti

MUNI/A/1336/2022, interní kód MU

Název: Vliv profylaktického podání fibrinogenu na velikost krevní ztráty u operací skoliózy: Monocentrická randomizovaná pilotní studie

Investor: Masarykova univerzita, Vliv profylaktického podání fibrinogenu na velikost krevní ztráty u operací skoliózy: Monocentrická randomizovaná pilotní studie

90249, velká výzkumná infrastruktura

Název: CZECRIN IV

Citovat

VRBICA, Kamil, Jan HUDEC, Ondřej HRDÝ, Michal GALKO, Hana HORALKOVA, Regina DEMLOVÁ, Michaela KUBELOVÁ, Martin REPKO a Roman GÁL. Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery (EFISS): a study protocol of two-arm, randomised trial. BMJ Open. London: BMJ Publishing Group, 2023, roč. 13, č. 5, s. 1-8. ISSN 2044-6055. Dostupné z: https://dx.doi.org/10.1136/bmjopen-2022-071547.

@article{2296077,
   author = {Vrbica, Kamil and Hudec, Jan and Hrdý, Ondřej and Galko, Michal and Horalkova, Hana and Demlová, Regina and Kubelová, Michaela and Repko, Martin and Gál, Roman},
   article_location = {London},
   article_number = {5},
   doi = {http://dx.doi.org/10.1136/bmjopen-2022-071547},
   keywords = {scoliosis; paediatrics; orthopaedic & trauma surgery; anaesthesia in orthopaedics; blood bank & transfusion medicine},
   language = {eng},
   issn = {2044-6055},
   journal = {BMJ Open},
   title = {Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery (EFISS): a study protocol of two-arm, randomised trial},
   url = {https://bmjopen.bmj.com/content/13/5/e071547},
   volume = {13},
   year = {2023}
}

TY  - JOUR
ID  - 2296077
AU  - Vrbica, Kamil - Hudec, Jan - Hrdý, Ondřej - Galko, Michal - Horalkova, Hana - Demlová, Regina - Kubelová, Michaela - Repko, Martin - Gál, Roman
PY  - 2023
TI  - Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery (EFISS): a study protocol of two-arm, randomised trial
JF  - BMJ Open
VL  - 13
IS  - 5
SP  - 1-8
EP  - 1-8
PB  - BMJ Publishing Group
SN  - 20446055
KW  - scoliosis
KW  - paediatrics
KW  - orthopaedic &
KW  - trauma surgery
KW  - anaesthesia in orthopaedics
KW  - blood bank &
KW  - transfusion medicine
UR  - https://bmjopen.bmj.com/content/13/5/e071547
N2  - 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.
ER  -

VRBICA, Kamil, Jan HUDEC, Ondřej HRDÝ, Michal GALKO, Hana HORALKOVA, Regina DEMLOVÁ, Michaela KUBELOVÁ, Martin REPKO a Roman GÁL. Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery (EFISS): a study protocol of two-arm, randomised trial. \textit{BMJ Open}. London: BMJ Publishing Group, 2023, roč.~13, č.~5, s.~1-8. ISSN~2044-6055. Dostupné z: https://dx.doi.org/10.1136/bmjopen-2022-071547.

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