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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trauma patients in shock | The study focuses on hypotensive trauma patients assisted by HEMS teams |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drugs administration | Drug | Antifibrinolytics, analgesics, sedatives, neuromuscular blocking agents |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30 days mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| survival from prehospital to hospital admmission | 1 day | |
| Hospital length of stay | 6 months | |
| Blood products transfused during the first 24 hours after hospital admission |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Tartaglione, MD | Contact | +390516368215 | marco.tartaglione@ausl.bologna.it | |
| Lorenzo Gamberini, MD | Contact | lorenzo.gamberini@ausl.bologna.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale di Alessandria | Recruiting | Alessandria | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25840537 | Background | 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. | |
| 26825635 | Result | 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. |
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| Resuscitative endovascular balloon occlusion of the aorta | Device | Resuscitative technique for exsanguinating traumas |
|
|
| Blood transfusions | Biological | Transfuion of transported blood products for exsanguinating traumas |
|
| Prehospital management | Other | Stay and play strategy vs scoop and run |
|
| Prehospital eFAST | Device | Prehospital thorax/abdomen extended focused assessment sonography for trauma |
|
| 24 hours |
| Transport time | time from dispatch to hospital admission (if any) | 24 hours |
| Base HEMS Aosta | Not yet recruiting | Aosta | Italy |
|
| Ospedale di Bolzano | Not yet recruiting | Bologna | Italy |
|
| Base HEMS Borgo Sesia | Not yet recruiting | Borgosesia | Italy |
|
| Base HEMS Cuneo-Levaldigi | Not yet recruiting | Cuneo | Italy |
|
| Ospedale Careggi Firenze | Not yet recruiting | Florence | Italy |
|
| Ospedale di Siena, Ospedale di Pisa | Recruiting | Grosseto | Italy |
|
| Ospedale di Siena, Ospedale di Pisa | Not yet recruiting | Massa | Italy |
|
| Ospedale di Padova | Not yet recruiting | Padova | Italy |
|
| Pavullo HEMS base | Not yet recruiting | Pavullo nel Frignano | Italy |
|
| Pieve di Cadore HEMS base | Not yet recruiting | Pieve di Cadore | Italy |
|
| Ospedale di Torino | Not yet recruiting | Torino | Italy |
|
| Base HEMS Trento | Not yet recruiting | Trento | Italy |
|
| Treviso hospital | Not yet recruiting | Treviso | Italy |
|
| Udine FVG | Not yet recruiting | Udine | Italy |
|
| Ospedale di Verona Borgo Trento | Not yet recruiting | Verona | Italy |
|
| 30917843 | Result | 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. |
| 27050884 | Result | 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. |
| 30741331 | Result | 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. |
| 35636792 | Derived | 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. |
| ID | Term |
|---|---|
| D007022 | Hypotension |
| D012769 | Shock |
| D014947 | Wounds and Injuries |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D000280 | Administration, Inhalation |
| D001803 | Blood Transfusion |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D001691 | Biological Therapy |
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