Managing low blood pressure in trauma patients before hospital arrival
Prehospital Management of Hypotensive Trauma in HEMS
Azienda Usl di Bologna · NCT04760977
This study looks at how helicopter emergency teams treat trauma patients with low blood pressure before they get to the hospital to see what methods help them recover better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Usl di Bologna (other gov) |
| Locations | 16 sites (Alessandria and 15 other locations) |
| Trial ID | NCT04760977 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the prehospital management of hypotensive trauma patients treated by helicopter emergency medical services (HEMS) in Italy. It aims to gather data on various factors related to prehospital care, including interventions like blood transfusions and resuscitative endovascular balloon occlusion of the aorta (REBOA), to assess their impact on in-hospital recovery and mortality. The study will enroll patients who have experienced a traumatic event and are in shock, collecting demographic and clinical data to identify best practices in emergency care. The findings could help standardize prehospital protocols across different regions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have experienced a witnessed traumatic event and are in shock upon evaluation.
Not a fit: Patients who are in cardiac arrest upon HEMS arrival and for whom resuscitation is not initiated will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and recovery outcomes for trauma patients experiencing hypotension.
How similar studies have performed: While there is limited evidence on the prehospital management of hypotensive trauma patients, emerging therapies like REBOA are being explored, indicating a need for further investigation in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Alessandria and 15 other locations
- 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 — Padova, 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)
Study contacts
- Study coordinator: Marco Tartaglione, MD
- Email: marco.tartaglione@ausl.bologna.it
- Phone: +390516368215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypotension and Shock, Wounds and Injuries, Emergencies, Critical Care, Transportation of Patients