Pre-trauma center red blood cell transfusion is associated with improved early outcomes in air medical trauma patients.
Joshua B Brown, Jason L Sperry, Anisleidy Fombona...
https://pubmed.ncbi.nlm.nih.gov/25840537Actively Recruiting
Age: 18Years +
All Genders
ID04760977
Prehospital Management of Hypotensive Trauma in HEMS
Led by Azienda Usl di Bologna · Updated on 2024-08-13
500
Participants Needed
16
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how best to manage patients with low blood pressure due to traumatic injuries before they reach the hospital. The study focuses on patients helped by helicopter emergency medical services (HEMS) across Italy, where emergency care practices vary widely. The goal is to understand how prehospital treatments affect hospital recovery and survival, especially for those with severe bleeding and shock. The study observes different prehospital treatments such as drug use including antifibrinolytics, pain relief, sedatives, and muscle relaxants. It also looks at advanced techniques like resuscitative endovascular balloon occlusion of the aorta (REBOA), blood transfusions, and ultrasound assessments for trauma. Care strategies like staying on scene for treatment versus rapid transport are also compared as part of usual prehospital management. Participants will have detailed data collected from the prehospital phase including demographics, trauma type, and treatments given. Hospital data such as blood transfusions, lab results, length of hospital and ICU stays, use of ventilation or kidney support, recovery, and survival will be analyzed. The main outcome measured is mortality within 30 days, with secondary outcomes including survival to hospital admission, hospital stay length, blood products used, and transport times. The study started in May 2021 and will continue until May 2026.
CONDITIONS
Brief Title
Prehospital Management of Hypotensive Trauma in HEMS
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Traumatic event managed by helicopter emergency medical services (HEMS)
- Shock at first evaluation with systolic blood pressure below 90 mmHg
- Suspected or obvious ongoing bleeding
You will not qualify if you...
- Patients in cardiac arrest at HEMS arrival where resuscitation is not started or has been stopped by HEMS crew
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - During prehospital care
Participants undergo prehospital thorax and abdomen sonography to assess trauma severity.
1 visit (in-person, prehospital)
Implementation
Duration - During prehospital care
Participants receive prehospital management including drug administration, resuscitative balloon occlusion, blood transfusions, and management strategies by HEMS teams.
1 visit (in-person, prehospital)
Monitoring
Duration - Up to 30 days
Participants are observed from prehospital care through hospital admission to monitor survival and treatment outcomes.
Visits as part of standard care during hospital stay
Trial Site Locations
Total: 16 locations
1
Ospedale di Alessandria
Alessandria, Italy
Actively Recruiting
2
Base HEMS Aosta
Aosta, Italy
Not Yet Recruiting
3
Ospedale di Bolzano
Bologna, Italy
Not Yet Recruiting
4
Base HEMS Borgo Sesia
Borgosesia, Italy
Not Yet Recruiting
5
Base HEMS Cuneo-Levaldigi
Cuneo, Italy
Not Yet Recruiting
6
Ospedale Careggi Firenze
Florence, Italy
Not Yet Recruiting
7
Ospedale di Siena, Ospedale di Pisa
Grosseto, Italy
Actively Recruiting
8
Ospedale di Siena, Ospedale di Pisa
Massa, Italy
Not Yet Recruiting
9
Ospedale di Padova
Padova, Italy
Not Yet Recruiting
10
Pavullo HEMS base
Pavullo nel Frignano, Italy
Not Yet Recruiting
11
Pieve di Cadore HEMS base
Pieve di Cadore, Italy
Not Yet Recruiting
12
Ospedale di Torino
Torino, Italy
Not Yet Recruiting
13
Base HEMS Trento
Trento, Italy
Not Yet Recruiting
14
Treviso hospital
Treviso, Italy
Not Yet Recruiting
15
Udine FVG
Udine, Italy
Not Yet Recruiting
16
Ospedale di Verona Borgo Trento
Verona, Italy
Not Yet Recruiting
Loading map...
Research Team
M
Marco Tartaglione, MD
L
Lorenzo Gamberini, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Prehospital Blood Product Resuscitation for Trauma: A Systematic Review.
Iain M Smith, Robert H James, Janine Dretzke...
https://pubmed.ncbi.nlm.nih.gov/26825635The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition.
Donat R Spahn, Bertil Bouillon, Vladimir Cerny...
https://pubmed.ncbi.nlm.nih.gov/30917843Shorter times to packed red blood cell transfusion are associated with decreased risk of death in traumatically injured patients.
Elizabeth K Powell, William R Hinckley, Adam Gottula...
https://pubmed.ncbi.nlm.nih.gov/27050884Why are bleeding trauma patients still dying?
Karim Brohi, Russell L Gruen, John B Holcomb
https://pubmed.ncbi.nlm.nih.gov/30741331Multicentre observational study on practice of prehospital management of hypotensive trauma patients: the SPITFIRE study protocol.
Marco Tartaglione, Luca Carenzo, Lorenzo Gamberini...
https://pubmed.ncbi.nlm.nih.gov/35636792