Clinical trial NCT04760977: Prehospital Management of Hypotensive Trauma in HEMS
Official title: Prehospital Management of Hypotensive Trauma in HEMS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypotension and Shock
Wounds and Injuries
Emergencies
Critical Care
Keywords: Transportation of Patients
Wounds and Injuries
Emergencies
Critical Care
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
First posted: 2021-02-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population object of study is represented by all the trauma patients managed by the HEMS crew that are experiencing a probable or obvious haemorragic shock

Brief summary: 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


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

Primary outcomes:
measure: 30 days mortality
timeFrame: 30 days
Secondary outcomes:
measure: survival from prehospital to hospital admmission
timeFrame: 1 day
measure: Hospital length of stay
timeFrame: 6 months
measure: Blood products transfused during the first 24 hours after hospital admission
timeFrame: 24 hours
measure: Transport time
timeFrame: 24 hours
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Ospedale di Alessandria
city: Aosta
country: Italy
facility: Base HEMS Aosta
city: Bologna
country: Italy
facility: Ospedale di Bolzano
city: Borgosesia
country: Italy
facility: Base HEMS Borgo Sesia
city: Cuneo
country: Italy
facility: Base HEMS Cuneo-Levaldigi
city: Firenze
country: Italy
facility: Ospedale Careggi Firenze
city: Grosseto
country: Italy
facility: Ospedale di Siena, Ospedale di Pisa
city: Massa
country: Italy
facility: Ospedale di Siena, Ospedale di Pisa
city: Padova
country: Italy
facility: Ospedale di Padova
city: Pavullo Nel Frignano
country: Italy
facility: Pavullo HEMS base
city: Pieve Di Cadore
country: Italy
facility: Pieve di Cadore HEMS base
city: Torino
country: Italy
facility: Ospedale di Torino
city: Trento
country: Italy
facility: Base HEMS Trento
city: Treviso
country: Italy
facility: Treviso hospital
city: Udine
country: Italy
facility: Udine FVG
city: Verona
country: Italy
facility: Ospedale di Verona Borgo Trento
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.