Multicentre observational study on practice of prehospital management of hypotensive trauma patients: the SPITFIRE study protocol

Marco Tartaglione, Luca Carenzo, Lorenzo Gamberini, Cristian Lupi, Aimone Giugni, Carlo Alberto Mazzoli, Valentina Chiarini, Silvia Cavagna, Davide Allegri, John B Holcomb, David Lockey, Giovanni Sbrana, Giovanni Gordini, Carlo Coniglio, SPITFIRE Study Collaborators, Luca Montagnani, Andrea Caglià, Jacopo Pernechele, Andrea Mina, Simona Cavallo, Roberto Vacca, Roberto Gioachin, Valeria Bonato, Claudia Monge, Paolo Frisoni, Luca Nicora, Giovanna Zilio, Cristina Barbarino, Andrea Paoli, Giacomo Magagnotti, Andrea Spagna, Alberto Trincanato, Francesca Verginella, Marta Pescolderung, Stefania Armani, Adriano Valerio, Giulio Desiderio, Edoardo Picetti, Michela Ciminello, Christian Tosato, Yuri Ferrara, Stefano Barbadori, Silvia Pini, Andrea Vignali, Alberto Baratta, Davide Durì, Calogero Centonze, Matteo Ciccolini, Alessandra Spasiano, Tommaso Marzano, Guido Gambetti, Domenico Minniti, Michela Rauseo, Gilda Cinnella, Tiziana Cena, Rosanna Vaschetto, Giacomo Iapichino, Tobias Gauss, Andrea Cortegiani, Fabio Genco, Antonio Iacono, Maria Teresa Strano, Annalisa Deiana, Marco Vidili, Massimiliano Carta, Alessio Ficarella, Flavia Baccari, Marco Tartaglione, Luca Carenzo, Lorenzo Gamberini, Cristian Lupi, Aimone Giugni, Carlo Alberto Mazzoli, Valentina Chiarini, Silvia Cavagna, Davide Allegri, John B Holcomb, David Lockey, Giovanni Sbrana, Giovanni Gordini, Carlo Coniglio, SPITFIRE Study Collaborators, Luca Montagnani, Andrea Caglià, Jacopo Pernechele, Andrea Mina, Simona Cavallo, Roberto Vacca, Roberto Gioachin, Valeria Bonato, Claudia Monge, Paolo Frisoni, Luca Nicora, Giovanna Zilio, Cristina Barbarino, Andrea Paoli, Giacomo Magagnotti, Andrea Spagna, Alberto Trincanato, Francesca Verginella, Marta Pescolderung, Stefania Armani, Adriano Valerio, Giulio Desiderio, Edoardo Picetti, Michela Ciminello, Christian Tosato, Yuri Ferrara, Stefano Barbadori, Silvia Pini, Andrea Vignali, Alberto Baratta, Davide Durì, Calogero Centonze, Matteo Ciccolini, Alessandra Spasiano, Tommaso Marzano, Guido Gambetti, Domenico Minniti, Michela Rauseo, Gilda Cinnella, Tiziana Cena, Rosanna Vaschetto, Giacomo Iapichino, Tobias Gauss, Andrea Cortegiani, Fabio Genco, Antonio Iacono, Maria Teresa Strano, Annalisa Deiana, Marco Vidili, Massimiliano Carta, Alessio Ficarella, Flavia Baccari

Abstract

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.

Keywords: accident & emergency medicine; intensive & critical care; trauma management.

Conflict of interest statement

Competing interests: JBH is a consultant with Cellphire, Hemostatics and Arsenal, is co-founder, co-CEO and on the Board of Directors of Decisio Health, on the Board of Directors of QinFlow, Zibrio and Oxyband and a co-inventor of the Junctional Emergency Tourniquet Tool. The other authors do not report any competing interest.

© 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.

Figures

Figure 1
Figure 1
Current study centres (February 2022). Blood drop represents HEMS bases with blood components availability. The Bolzano icon represents the four Alto Adige provincial bases: Bolzano, Bressanone, Lasa and Pontives. HEMS, Helicopter Emergency Medical Services.

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