Prehospital Management of Hypotensive Trauma in HEMS

Emergencies Clinical Trial

— SPITFIRE  

Official title:

Prehospital Management of Hypotensive Trauma in HEMS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04760977
• Other study ID #: 959-2020-OSS-AUSLBO
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: May 1, 2026

Study information

• Verified date: February 2022
• Source: Azienda Usl di Bologna
• Contact: Marco Tartaglione, MD
• Phone: +390516368215
• Email: marco.tartaglione[@]ausl.bologna.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Care
• Emergencies
• Hypotension
• Hypotension and Shock
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Italy	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	Firenze
Italy	Ospedale di Siena, Ospedale di Pisa	Grosseto
Italy	Ospedale di Siena, Ospedale di Pisa	Massa
Italy	Ospedale di Padova	Padova
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

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Usl di Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. — View 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: 1 — View 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. Review. — View 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 Ca — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 days mortality		30 days
Secondary	survival from prehospital to hospital admmission		1 day
Secondary	Hospital length of stay		6 months
Secondary	Blood products transfused during the first 24 hours after hospital admission		24 hours
Secondary	Transport time	time from dispatch to hospital admission (if any)	24 hours