NCT04760977 Prehospital Management of Hypotensive Trauma in HEMS
| NCT ID | NCT04760977 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Usl di Bologna |
| Condition | Hypotension and Shock |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2021-05-01 |
| Primary Completion | 2025-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2021-05-01 with a primary completion date of 2025-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04760977 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypotension and Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04760977 currently recruiting?
Yes, NCT04760977 is actively recruiting participants. Contact the research team at marco.tartaglione@ausl.bologna.it for enrollment information.
Where is the NCT04760977 trial being conducted?
This trial is being conducted at Alessandria, Italy, Aosta, Italy, Bologna, Italy, Borgosesia, Italy and 11 additional locations.
Who is sponsoring the NCT04760977 clinical trial?
NCT04760977 is sponsored by Azienda Usl di Bologna. The trial plans to enroll 500 participants.