Hypotension and ShockSPITFIRENCT04760977
Prehospital Management of Hypotensive Trauma in HEMS
An observational study of Hypotension and Shock and Wounds and Injuries, run by Azienda Usl di Bologna at 16 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension and Shock, Wounds and Injuries, Emergencies
- How many people
- 1,268 participants
- Where
- 16 sitesItaly
- Study dates
- 1 May 2021to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age > 18 years
- Witnessed traumatic event managed by HEMS
- Shock at first evaluation (Systolic blood pressure < 90 mmHg)
- Suspect or obvious ongoing haemorrage
Who cannot join
- Patients in cardiac arrest at HEMS arrival in which resuscitation is not started or interrupted by HEMS crew
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Italy16 sites
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
Ospedale di Padova
Padova
Pavullo HEMS base
Pavullo nel Frignano, Italy
Pieve di Cadore HEMS base
Pieve di Cadore, Italy
Ospedale di Torino
Torino
Base HEMS Trento
Trento
Treviso hospital
Treviso, Italy
Udine FVG
Udine, Italy
Ospedale di Verona Borgo Trento
Verona
About this study
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.
Read more
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
- Conditions
- Hypotension and Shock, Wounds and Injuries, Emergencies, Critical Care
- Keywords
- Transportation of Patients, Wounds and Injuries, Emergencies, Critical Care
- Medical subject headings
- Hypotension, Shock, Wounds and Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients received prehospital blood products | patients received prehospital blood products | |
| patients did not received any prehospital blood products | patients did not received any prehospital blood products |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at 24 hours
Measured: 24 hours from first prehospital physician contact
All-cause mortality at 7 days
Measured: 7 days from first prehospital physician contact
All-cause mortality at 30 days
Measured: 30 days from first prehospital physician contact
Secondary outcomes (4)
survival from prehospital to hospital admmission
Measured: 1 day
Hospital length of stay
Measured: 6 months
Blood products transfused during the first 24 hours after hospital admission
Measured: 24 hours
Transport time
time from dispatch to hospital admission (if any)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 May 2021
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hypotension and ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760977
- Sponsor's protocol ID
- 959-2020-OSS-AUSLBO
- Acronym
- SPITFIRE
- Status last verified
- Oct 2026
- First submitted
- 16 Feb 2021
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35636792Brown 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.
PubMed 25840537Smith 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.
PubMed 26825635Spahn 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.
PubMed 30917843Powell 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.
PubMed 27050884Brohi 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.
PubMed 30741331
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Management of Hypotensive Trauma in HEMS
- ClinicalTrials.gov ID
- NCT04760977
- Acronym / sponsor ID
- SPITFIRE / 959-2020-OSS-AUSLBO
- Conditions
- Hypotension and Shock, Wounds and Injuries, Emergencies, Critical Care
- Keywords
- Transportation of Patients, Wounds and Injuries, Emergencies, Critical Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,268 participants (actual)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients received prehospital blood products | – | –patients received prehospital blood products |
| patients did not received any prehospital blood products | – | –patients did not received any prehospital blood products |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Age > 18 years
- Witnessed traumatic event managed by HEMS
- Shock at first evaluation (Systolic blood pressure < 90 mmHg)
- Suspect or obvious ongoing haemorrage
Key exclusion criteria (1 listed)
- Patients in cardiac arrest at HEMS arrival in which resuscitation is not started or interrupted by HEMS crew
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality at 24 hours
Time frame: 24 hours from first prehospital physician contact
All-cause mortality at 7 days
Time frame: 7 days from first prehospital physician contact
All-cause mortality at 30 days
Time frame: 30 days from first prehospital physician contact
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 35636792Tartaglione 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.
- Background: PubMed 25840537Brown 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.
- Results publication: PubMed 26825635Smith 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.
- Results publication: PubMed 30917843Spahn 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.
- Results publication: PubMed 27050884Powell 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.
- Results publication: PubMed 30741331Brohi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension and Shock and Wounds and Injuries, run by Azienda Usl di Bologna at 16 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality at 24 hours (time frame: 24 hours from first prehospital physician contact). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04760977, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.