Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2021-05-01
2026-05-01
Brief Summary
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Also new emerging therapies such as prehospital blood transfusion and REBOA (resuscitative endovascular balloon occlusion of the aorta) are lacking strong evidences in, eventually, reducing hospital mortality and improving outcomes.
Moreover, prehospital emergency medicine is throughout Italy an heterogeneous system that has no unique standard operating procedures and, even among HEMS (helicopter emergency medical service), management and therapies on complex trauma patients may vary upon local policies.
With this study we aim to enroll hypotensive trauma patients and study factors of prehospital rescue that can be associated with in-hospital mortality and recovery, eventually even with hospital outcome. For each patients data as demographic, kind of trauma (mechanism, injury scores), therapies and maneuvers will be recorded and then analyzed in comparison with in-hospital data such as need for transfusion, ABG parameters, length of stay (in-ward and ICU), need of therapies like invasive ventilation and renal replacement therapy, recovery and outcome
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Trauma patients in shock
The study focuses on hypotensive trauma patients assisted by HEMS teams
Drugs administration
Antifibrinolytics, analgesics, sedatives, neuromuscular blocking agents
Resuscitative endovascular balloon occlusion of the aorta
Resuscitative technique for exsanguinating traumas
Blood transfusions
Transfuion of transported blood products for exsanguinating traumas
Prehospital management
Stay and play strategy vs scoop and run
Prehospital eFAST
Prehospital thorax/abdomen extended focused assessment sonography for trauma
Interventions
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Drugs administration
Antifibrinolytics, analgesics, sedatives, neuromuscular blocking agents
Resuscitative endovascular balloon occlusion of the aorta
Resuscitative technique for exsanguinating traumas
Blood transfusions
Transfuion of transported blood products for exsanguinating traumas
Prehospital management
Stay and play strategy vs scoop and run
Prehospital eFAST
Prehospital thorax/abdomen extended focused assessment sonography for trauma
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Witnessed traumatic event managed by HEMS
* Shock at first evaluation (Systolic blood pressure \< 90 mmHg)
* Suspect or obvious ongoing haemorrage
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Azienda Usl di Bologna
OTHER_GOV
Responsible Party
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Locations
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Ospedale di Alessandria
Alessandria, , Italy
Base HEMS Aosta
Aosta, , Italy
Ospedale di Bolzano
Bologna, , Italy
Base HEMS Borgo Sesia
Borgosesia, , Italy
Base HEMS Cuneo-Levaldigi
Cuneo, , Italy
Ospedale Careggi Firenze
Florence, , Italy
Ospedale di Siena, Ospedale di Pisa
Grosseto, , Italy
Ospedale di Siena, Ospedale di Pisa
Massa, , Italy
Ospedale di Padova
Padua, , Italy
Pavullo HEMS base
Pavullo nel Frignano, , Italy
Pieve di Cadore HEMS base
Pieve di Cadore, , Italy
Ospedale di Torino
Torino, , Italy
Base HEMS Trento
Trento, , Italy
Treviso hospital
Treviso, , Italy
Udine FVG
Udine, , Italy
Ospedale di Verona Borgo Trento
Verona, , Italy
Countries
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Central Contacts
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Facility Contacts
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Andrea Mina
Role: primary
Simona Cavallo
Role: backup
Andrea Caglià
Role: primary
Francesca Verginella
Role: primary
Andrea Mina
Role: primary
Simona Cavallo
Role: backup
Andrea Mina
Role: primary
Simona Cavallo
Role: backup
Mario Rugna
Role: primary
Giovanni Sbrana
Role: primary
Silvia Pini
Role: primary
Andrea Vignali
Role: backup
Andrea Paoli
Role: primary
Andrea Mina
Role: primary
Simona Cavallo
Role: backup
Vittorio Albarello
Role: primary
Giacomo Magagnotti
Role: primary
References
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Brown JB, Sperry JL, Fombona A, Billiar TR, Peitzman AB, Guyette FX. Pre-trauma center red blood cell transfusion is associated with improved early outcomes in air medical trauma patients. J Am Coll Surg. 2015 May;220(5):797-808. doi: 10.1016/j.jamcollsurg.2015.01.006. Epub 2015 Jan 24.
Smith IM, James RH, Dretzke J, Midwinter MJ. Prehospital Blood Product Resuscitation for Trauma: A Systematic Review. Shock. 2016 Jul;46(1):3-16. doi: 10.1097/SHK.0000000000000569.
Spahn DR, Bouillon B, Cerny V, Duranteau J, Filipescu D, Hunt BJ, Komadina R, Maegele M, Nardi G, Riddez L, Samama CM, Vincent JL, Rossaint R. The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition. Crit Care. 2019 Mar 27;23(1):98. doi: 10.1186/s13054-019-2347-3.
Powell EK, Hinckley WR, Gottula A, Hart KW, Lindsell CJ, McMullan JT. Shorter times to packed red blood cell transfusion are associated with decreased risk of death in traumatically injured patients. J Trauma Acute Care Surg. 2016 Sep;81(3):458-62. doi: 10.1097/TA.0000000000001078.
Brohi K, Gruen RL, Holcomb JB. Why are bleeding trauma patients still dying? Intensive Care Med. 2019 May;45(5):709-711. doi: 10.1007/s00134-019-05560-x. Epub 2019 Feb 11. No abstract available.
Tartaglione M, Carenzo L, Gamberini L, Lupi C, Giugni A, Mazzoli CA, Chiarini V, Cavagna S, Allegri D, Holcomb JB, Lockey D, Sbrana G, Gordini G, Coniglio C; SPITFIRE Study Collaborators. Multicentre observational study on practice of prehospital management of hypotensive trauma patients: the SPITFIRE study protocol. BMJ Open. 2022 May 30;12(5):e062097. doi: 10.1136/bmjopen-2022-062097.
Other Identifiers
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959-2020-OSS-AUSLBO
Identifier Type: -
Identifier Source: org_study_id
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