Prehospital Management of Hypotensive Trauma in HEMS

NCT04760977 | Recruiting

• 1 other identifier: 959-2020-OSS-AUSLBO
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 16

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

Conditions

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

Keywords

Transportation of Patients; Wounds and Injuries; Emergencies; Critical Care

Outcome Measures

Primary Outcomes (1)

• 30 days mortality

  30 days

Secondary Outcomes (4)

• 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

  24 hours

• Transport time

  24 hours

Study Arms (1)

Trauma patients in shock

The study focuses on hypotensive trauma patients assisted by HEMS teams

Drug: Drugs administration; Device: Resuscitative endovascular balloon occlusion of the aorta; Biological: Blood transfusions; Other: Prehospital management; Device: Prehospital eFAST

Interventions

Drugs administration DRUG

Antifibrinolytics, analgesics, sedatives, neuromuscular blocking agents

Trauma patients in shock

Resuscitative endovascular balloon occlusion of the aorta DEVICE

Resuscitative technique for exsanguinating traumas

Also known as: REBOA

Trauma patients in shock

Blood transfusions BIOLOGICAL

Transfuion of transported blood products for exsanguinating traumas

Trauma patients in shock

Prehospital management OTHER

Stay and play strategy vs scoop and run

Trauma patients in shock

Prehospital eFAST DEVICE

Prehospital thorax/abdomen extended focused assessment sonography for trauma

Trauma patients in shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age \> 18 years
• Witnessed traumatic event managed by HEMS
• Shock at first evaluation (Systolic blood pressure \< 90 mmHg)
• Suspect or obvious ongoing haemorrage

You may not qualify if:

• Patients in cardiac arrest at HEMS arrival in which resuscitation is not started or interrupted by HEMS crew

Sponsors & Collaborators

• Azienda Usl di Bologna: lead

Study Sites (16)

Ospedale di Alessandria

Alessandria, Italy

RECRUITING

Base HEMS Aosta

Aosta, Italy

NOT YET RECRUITING

Ospedale di Bolzano

Bologna, Italy

NOT YET RECRUITING

Base HEMS Borgo Sesia

Borgosesia, Italy

NOT YET RECRUITING

Base HEMS Cuneo-Levaldigi

Cuneo, Italy

NOT YET RECRUITING

Ospedale Careggi Firenze

Florence, Italy

NOT YET RECRUITING

Ospedale di Siena, Ospedale di Pisa

Grosseto, Italy

RECRUITING

Ospedale di Siena, Ospedale di Pisa

Massa, Italy

NOT YET RECRUITING

Ospedale di Padova

Padua, Italy

NOT YET RECRUITING

Pavullo HEMS base

Pavullo nel Frignano, Italy

NOT YET RECRUITING

Pieve di Cadore HEMS base

Pieve di Cadore, Italy

NOT YET RECRUITING

Ospedale di Torino

Torino, Italy

NOT YET RECRUITING

Base HEMS Trento

Trento, Italy

NOT YET RECRUITING

Treviso hospital

Treviso, Italy

NOT YET RECRUITING

Udine FVG

Udine, Italy

NOT YET RECRUITING

Ospedale di Verona Borgo Trento

Verona, Italy

NOT YET RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 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.

  PMID: 30917843 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.

  PMID: 27050884 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.

  PMID: 30741331 RESULT

• 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 DERIVED

MeSH Terms

Conditions

Hypotension; Shock; Wounds and Injuries; Emergencies

Interventions

Administration, Inhalation; Blood Transfusion

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Biological Therapy

Central Study Contacts

Marco Tartaglione, MD

CONTACT

+390516368215; marco.tartaglione@ausl.bologna.it

Lorenzo Gamberini, MD

CONTACT

lorenzo.gamberini@ausl.bologna.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 18, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (16)