Effect of prophylactic fibrinogen concentrate in scoliosis surgery (EFISS): a randomised pilot trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F25%3A00082799" target="_blank" >RIV/65269705:_____/25:00082799 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216224:14110/25:00142320

Výsledek na webu

<a href="https://bmjopen.bmj.com/content/15/10/e100137.long" target="_blank" >https://bmjopen.bmj.com/content/15/10/e100137.long</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1136/bmjopen-2025-100137" target="_blank" >10.1136/bmjopen-2025-100137</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Effect of prophylactic fibrinogen concentrate in scoliosis surgery (EFISS): a randomised pilot trial

Popis výsledku v původním jazyce

OBJECTIVES: The goal of this study is to assess the safety, feasibility and clinical outcomes of prophylactic fibrinogen administration in paediatric scoliosis surgery. DESIGN: Prospective, two-arm, randomised, double-blind pilot trial. SETTING: Single-centre study conducted at a tertiary care hospital specialising in scoliosis surgery. PARTICIPANTS: 32 children undergoing scoliosis surgery entered and completed the study. The inclusion criteria were elective scoliosis surgery, age &lt;18 years, provision of a signed informed consent form by both parents and consent to contraception use for the duration of this clinical trial among sexually active (GREATER-THAN OR EQUAL TO15 years of age) participants. The exclusion criteria were diagnosed congenital or acquired coagulopathy, use of anticoagulants other than perioperative prophylactic administration of low molecular weight heparin to prevent venous thromboembolism, known hypersensitivity to the active substance or any excipients in the investigated medicinal product, history of deep vein thrombosis or pulmonary embolism, pregnancy and lactation. INTERVENTIONS: Participants were randomised 1:1 to a standard group, receiving standard blood and coagulation management, or a fibrinogen group, receiving a single prophylactic dose of fibrinogen concentrate in addition to standard care. PRIMARY AND SECONDARY OUTCOME MEASURES: Safety, the primary objective, was assessed according to adverse events, serious adverse events and other safety parameters. Secondary objectives included feasibility and clinical outcomes. RESULTS: In the fibrinogen group, 101 adverse events across 19 types were observed, whereas in the standard group, 95 adverse events across 21 types (p&gt;0.9999) and one serious adverse event were observed. No adverse events of special interest or deaths occurred in either group. Blood loss did not significantly differ between the fibrinogen (1021.88 mL (SD 473.63)) and standard (859.38 mL (SD 713.03)) groups (p=0.1677). The mean length of hospital stay was 8.88 (SD 0.81) days in the fibrinogen group and 9.25 (SD 1.88) days in the standard group (p=0.9210). No statistically significant differences in the use of blood transfusions, blood derivatives, crystalloids or colloids were observed between groups. CONCLUSIONS: This study demonstrates that the prophylactic administration of fibrinogen during scoliosis surgery in children is feasible and appears to be safe. Due to the limited sample size, no conclusions can be drawn regarding the efficacy of pre-emptive fibrinogen administration on clinical outcomes. However, the results provide valuable data to inform sample size calculation for a future full-scale randomised controlled trial. TRIAL REGISTRATION NUMBER: CliniacalTrials.gov NCT05391412.

Název v anglickém jazyce

Effect of prophylactic fibrinogen concentrate in scoliosis surgery (EFISS): a randomised pilot trial

Popis výsledku anglicky

OBJECTIVES: The goal of this study is to assess the safety, feasibility and clinical outcomes of prophylactic fibrinogen administration in paediatric scoliosis surgery. DESIGN: Prospective, two-arm, randomised, double-blind pilot trial. SETTING: Single-centre study conducted at a tertiary care hospital specialising in scoliosis surgery. PARTICIPANTS: 32 children undergoing scoliosis surgery entered and completed the study. The inclusion criteria were elective scoliosis surgery, age &lt;18 years, provision of a signed informed consent form by both parents and consent to contraception use for the duration of this clinical trial among sexually active (GREATER-THAN OR EQUAL TO15 years of age) participants. The exclusion criteria were diagnosed congenital or acquired coagulopathy, use of anticoagulants other than perioperative prophylactic administration of low molecular weight heparin to prevent venous thromboembolism, known hypersensitivity to the active substance or any excipients in the investigated medicinal product, history of deep vein thrombosis or pulmonary embolism, pregnancy and lactation. INTERVENTIONS: Participants were randomised 1:1 to a standard group, receiving standard blood and coagulation management, or a fibrinogen group, receiving a single prophylactic dose of fibrinogen concentrate in addition to standard care. PRIMARY AND SECONDARY OUTCOME MEASURES: Safety, the primary objective, was assessed according to adverse events, serious adverse events and other safety parameters. Secondary objectives included feasibility and clinical outcomes. RESULTS: In the fibrinogen group, 101 adverse events across 19 types were observed, whereas in the standard group, 95 adverse events across 21 types (p&gt;0.9999) and one serious adverse event were observed. No adverse events of special interest or deaths occurred in either group. Blood loss did not significantly differ between the fibrinogen (1021.88 mL (SD 473.63)) and standard (859.38 mL (SD 713.03)) groups (p=0.1677). The mean length of hospital stay was 8.88 (SD 0.81) days in the fibrinogen group and 9.25 (SD 1.88) days in the standard group (p=0.9210). No statistically significant differences in the use of blood transfusions, blood derivatives, crystalloids or colloids were observed between groups. CONCLUSIONS: This study demonstrates that the prophylactic administration of fibrinogen during scoliosis surgery in children is feasible and appears to be safe. Due to the limited sample size, no conclusions can be drawn regarding the efficacy of pre-emptive fibrinogen administration on clinical outcomes. However, the results provide valuable data to inform sample size calculation for a future full-scale randomised controlled trial. TRIAL REGISTRATION NUMBER: CliniacalTrials.gov NCT05391412.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30218 - General and internal medicine

Projekt

<a href="/cs/project/LM2023049" target="_blank" >LM2023049: Český národní uzel Evropské sítě infrastruktur klinického výzkumu</a><br>

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

BMJ Open

ISSN

2044-6055

e-ISSN

2044-6055

Svazek periodika

15

Číslo periodika v rámci svazku

10

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

10

Strana od-do

"e100137"

Kód UT WoS článku

001591372600001

EID výsledku v databázi Scopus

2-s2.0-105018084259