Multicentre observational study on practice of prehospital management of hypotensive trauma patients : the SPITFIRE study protocol
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
INTRODUCTION: Major haemorrhage after injury is the leading cause of preventable death for trauma patients. Recent advancements in trauma care suggest damage control resuscitation (DCR) should start in the prehospital phase following major trauma. In Italy, Helicopter Emergency Medical Services (HEMS) assist the most complex injuries and deliver the most advanced interventions including DCR. The effect size of DCR delivered prehospitally on survival remains however unclear.
METHODS AND ANALYSIS: This is an investigator-initiated, large, national, prospective, observational cohort study aiming to recruit >500 patients in haemorrhagic shock after major trauma. We aim at describing the current practice of hypotensive trauma management as well as propose the creation of a national registry of patients with haemorrhagic shock.
PRIMARY OBJECTIVE: the exploration of the effect size of the variation in clinical practice on the mortality of hypotensive trauma patients. The primary outcome measure will be 24 hours, 7-day and 30-day mortality. Secondary outcomes include: association of prehospital factors and survival from injury to hospital admission, hospital length of stay, prehospital and in-hospital complications, hospital outcomes; use of prehospital ultrasound; association of prehospital factors and volume of first 24-hours blood product administration and evaluation of the prevalence of use, appropriateness, haemodynamic, metabolic and effects on mortality of prehospital blood transfusions.
INCLUSION CRITERIA: age >18 years, traumatic injury attended by a HEMS team including a physician, a systolic blood pressure <90 mm Hg or weak/absent radial pulse and a confirmed or clinically likely diagnosis of major haemorrhage. Prehospital and in-hospital variables will be collected to include key times, clinical findings, examinations and interventions. Patients will be followed-up until day 30 from admission. The Glasgow Outcome Scale Extended will be collected at 30 days from admission.
ETHICS AND DISSEMINATION: The study has been approved by the Ethics committee 'Comitato Etico di Area Vasta Emilia Centro'. Data will be disseminated to the scientific community by abstracts submitted to international conferences and by original articles submitted to peer-reviewed journals.
TRIAL REGISTRATION NUMBER: NCT04760977.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
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| Enthalten in: |
BMJ open - 12(2022), 5 vom: 30. Mai, Seite e062097 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Tartaglione, Marco [VerfasserIn] |
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| Links: |
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| Themen: |
Accident & emergency medicine |
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| Anmerkungen: |
Date Completed 02.06.2022 Date Revised 16.07.2022 published: Electronic ClinicalTrials.gov: NCT04760977 Citation Status MEDLINE |
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| doi: |
10.1136/bmjopen-2022-062097 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 500 | |a Date Revised 16.07.2022 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04760977 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a INTRODUCTION: Major haemorrhage after injury is the leading cause of preventable death for trauma patients. Recent advancements in trauma care suggest damage control resuscitation (DCR) should start in the prehospital phase following major trauma. In Italy, Helicopter Emergency Medical Services (HEMS) assist the most complex injuries and deliver the most advanced interventions including DCR. The effect size of DCR delivered prehospitally on survival remains however unclear | ||
| 520 | |a METHODS AND ANALYSIS: This is an investigator-initiated, large, national, prospective, observational cohort study aiming to recruit >500 patients in haemorrhagic shock after major trauma. We aim at describing the current practice of hypotensive trauma management as well as propose the creation of a national registry of patients with haemorrhagic shock | ||
| 520 | |a PRIMARY OBJECTIVE: the exploration of the effect size of the variation in clinical practice on the mortality of hypotensive trauma patients. The primary outcome measure will be 24 hours, 7-day and 30-day mortality. Secondary outcomes include: association of prehospital factors and survival from injury to hospital admission, hospital length of stay, prehospital and in-hospital complications, hospital outcomes; use of prehospital ultrasound; association of prehospital factors and volume of first 24-hours blood product administration and evaluation of the prevalence of use, appropriateness, haemodynamic, metabolic and effects on mortality of prehospital blood transfusions | ||
| 520 | |a INCLUSION CRITERIA: age >18 years, traumatic injury attended by a HEMS team including a physician, a systolic blood pressure <90 mm Hg or weak/absent radial pulse and a confirmed or clinically likely diagnosis of major haemorrhage. Prehospital and in-hospital variables will be collected to include key times, clinical findings, examinations and interventions. Patients will be followed-up until day 30 from admission. The Glasgow Outcome Scale Extended will be collected at 30 days from admission | ||
| 520 | |a ETHICS AND DISSEMINATION: The study has been approved by the Ethics committee 'Comitato Etico di Area Vasta Emilia Centro'. Data will be disseminated to the scientific community by abstracts submitted to international conferences and by original articles submitted to peer-reviewed journals | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT04760977 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a accident & emergency medicine | |
| 650 | 4 | |a intensive & critical care | |
| 650 | 4 | |a trauma management | |
| 700 | 1 | |a Carenzo, Luca |e verfasserin |4 aut | |
| 700 | 1 | |a Gamberini, Lorenzo |e verfasserin |4 aut | |
| 700 | 1 | |a Lupi, Cristian |e verfasserin |4 aut | |
| 700 | 1 | |a Giugni, Aimone |e verfasserin |4 aut | |
| 700 | 1 | |a Mazzoli, Carlo Alberto |e verfasserin |4 aut | |
| 700 | 1 | |a Chiarini, Valentina |e verfasserin |4 aut | |
| 700 | 1 | |a Cavagna, Silvia |e verfasserin |4 aut | |
| 700 | 1 | |a Allegri, Davide |e verfasserin |4 aut | |
| 700 | 1 | |a Holcomb, John B |e verfasserin |4 aut | |
| 700 | 1 | |a Lockey, David |e verfasserin |4 aut | |
| 700 | 1 | |a Sbrana, Giovanni |e verfasserin |4 aut | |
| 700 | 1 | |a Gordini, Giovanni |e verfasserin |4 aut | |
| 700 | 1 | |a Coniglio, Carlo |e verfasserin |4 aut | |
| 700 | 0 | |a SPITFIRE Study Collaborators |e verfasserin |4 aut | |
| 700 | 1 | |a Montagnani, Luca |e investigator |4 oth | |
| 700 | 1 | |a Caglià, Andrea |e investigator |4 oth | |
| 700 | 1 | |a Pernechele, Jacopo |e investigator |4 oth | |
| 700 | 1 | |a Mina, Andrea |e investigator |4 oth | |
| 700 | 1 | |a Cavallo, Simona |e investigator |4 oth | |
| 700 | 1 | |a Vacca, Roberto |e investigator |4 oth | |
| 700 | 1 | |a Gioachin, Roberto |e investigator |4 oth | |
| 700 | 1 | |a Bonato, Valeria |e investigator |4 oth | |
| 700 | 1 | |a Monge, Claudia |e investigator |4 oth | |
| 700 | 1 | |a Frisoni, Paolo |e investigator |4 oth | |
| 700 | 1 | |a Nicora, Luca |e investigator |4 oth | |
| 700 | 1 | |a Zilio, Giovanna |e investigator |4 oth | |
| 700 | 1 | |a Barbarino, Cristina |e investigator |4 oth | |
| 700 | 1 | |a Paoli, Andrea |e investigator |4 oth | |
| 700 | 1 | |a Magagnotti, Giacomo |e investigator |4 oth | |
| 700 | 1 | |a Spagna, Andrea |e investigator |4 oth | |
| 700 | 1 | |a Trincanato, Alberto |e investigator |4 oth | |
| 700 | 1 | |a Verginella, Francesca |e investigator |4 oth | |
| 700 | 1 | |a Pescolderung, Marta |e investigator |4 oth | |
| 700 | 1 | |a Armani, Stefania |e investigator |4 oth | |
| 700 | 1 | |a Valerio, Adriano |e investigator |4 oth | |
| 700 | 1 | |a Desiderio, Giulio |e investigator |4 oth | |
| 700 | 1 | |a Picetti, Edoardo |e investigator |4 oth | |
| 700 | 1 | |a Ciminello, Michela |e investigator |4 oth | |
| 700 | 1 | |a Tosato, Christian |e investigator |4 oth | |
| 700 | 1 | |a Ferrara, Yuri |e investigator |4 oth | |
| 700 | 1 | |a Barbadori, Stefano |e investigator |4 oth | |
| 700 | 1 | |a Pini, Silvia |e investigator |4 oth | |
| 700 | 1 | |a Vignali, Andrea |e investigator |4 oth | |
| 700 | 1 | |a Baratta, Alberto |e investigator |4 oth | |
| 700 | 1 | |a Durì, Davide |e investigator |4 oth | |
| 700 | 1 | |a Centonze, Calogero |e investigator |4 oth | |
| 700 | 1 | |a Ciccolini, Matteo |e investigator |4 oth | |
| 700 | 1 | |a Spasiano, Alessandra |e investigator |4 oth | |
| 700 | 1 | |a Marzano, Tommaso |e investigator |4 oth | |
| 700 | 1 | |a Gambetti, Guido |e investigator |4 oth | |
| 700 | 1 | |a Minniti, Domenico |e investigator |4 oth | |
| 700 | 1 | |a Rauseo, Michela |e investigator |4 oth | |
| 700 | 1 | |a Cinnella, Gilda |e investigator |4 oth | |
| 700 | 1 | |a Cena, Tiziana |e investigator |4 oth | |
| 700 | 1 | |a Vaschetto, Rosanna |e investigator |4 oth | |
| 700 | 1 | |a Iapichino, Giacomo |e investigator |4 oth | |
| 700 | 1 | |a Gauss, Tobias |e investigator |4 oth | |
| 700 | 1 | |a Cortegiani, Andrea |e investigator |4 oth | |
| 700 | 1 | |a Genco, Fabio |e investigator |4 oth | |
| 700 | 1 | |a Iacono, Antonio |e investigator |4 oth | |
| 700 | 1 | |a Strano, Maria Teresa |e investigator |4 oth | |
| 700 | 1 | |a Deiana, Annalisa |e investigator |4 oth | |
| 700 | 1 | |a Vidili, Marco |e investigator |4 oth | |
| 700 | 1 | |a Carta, Massimiliano |e investigator |4 oth | |
| 700 | 1 | |a Ficarella, Alessio |e investigator |4 oth | |
| 700 | 1 | |a Baccari, Flavia |e investigator |4 oth | |
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