Prehospital Management of Hypotensive Trauma in HEMS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Drugs administration, Resuscitative endovascular balloon occlusion of the aorta, Blood transfusions, Prehospital management.
- Who it may be relevant to
- Registry conditions: Hypotension and Shock, Wounds and Injuries, Emergencies, Critical Care. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Up to today, inadequate evidences and knowledge exist about the best prehospital management of hypotensive trauma patients and its clinical consequence on the in-hospital recovery and mortality. 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
Interventions
- Drug Drugs administration
Antifibrinolytics, analgesics, sedatives, neuromuscular blocking agents - Device Resuscitative endovascular balloon occlusion of the aorta
Resuscitative technique for exsanguinating traumas - Biological Blood transfusions
Transfuion of transported blood products for exsanguinating traumas - Other Prehospital management
Stay and play strategy vs scoop and run - Device Prehospital eFAST
Prehospital thorax/abdomen extended focused assessment sonography for trauma
Primary outcome measures
- 30 days mortality [Time frame: 30 days]
Secondary outcome measures (4)
- survival from prehospital to hospital admmission [Time frame: 1 day]
- Hospital length of stay [Time frame: 6 months]
- Blood products transfused during the first 24 hours after hospital admission [Time frame: 24 hours]
- Transport time [Time frame: 24 hours]
Eligibility criteria
Inclusion criteria
- Age > 18 years
- Witnessed traumatic event managed by HEMS
- Shock at first evaluation (Systolic blood pressure < 90 mmHg)
- Suspect or obvious ongoing haemorrage
Exclusion criteria
- Patients in cardiac arrest at HEMS arrival in which resuscitation is not started or interrupted by HEMS crew
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 16 centers
- Ospedale di Alessandria — Alessandria
- Base HEMS Aosta — Aosta
- Ospedale di Bolzano — Bologna
- Base HEMS Borgo Sesia — Borgosesia
- Base HEMS Cuneo-Levaldigi — Cuneo
- Ospedale Careggi Firenze — Florence
- Ospedale di Siena, Ospedale di Pisa — Grosseto
- Ospedale di Siena, Ospedale di Pisa — Massa
- … and 8 more centers
Publications
- 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. PMID 25840537
- 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. PMID 26825635
- 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. PMID 30917843
- 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. PMID 27050884
- 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. PMID 30741331
- 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. PMID 35636792
Identifiers
NCT: NCT04760977 · 959-2020-OSS-AUSLBO