Hemorrhagic shock
Conditions
Interventions
Prehospital treatment algorithm. The treatment algorithm includes several interventions that are considered standard care in emergency department trauma care, such as early femoral artery access and i
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: Estimated age 16 years or oldera) Penetrating trauma between the groin and diaphragm AND class 3 or higher hemorrhagic shock OR witnessed traumatic cardiac arrest < 5 minutes before HEMS arrival (witnessed by EMS or HEMS)ORb) Blunt trauma with evidence of NCTH in the form of (1) fracture of the pelvis or (2) free intraperitoneal fluid on abdominal ultrasound examination AND class 3 or higher hemorrhagic shock OR witnessed traumatic cardiac arrest < 5 minutes before HEMS arrival (witnessed by EMS or HEMS)Planned direct transfer to participating trauma center
Exclusion criteria
Exclusion criteria: Nonsurvivable injuries (e.g., gunshot wound to the head)Scene in proximity of participating trauma center, time between HEMS arrival on scene and ED REBOA placement less than 10 minutesCatastrophic intrathoracic hemorrhage on ultrasound examination or finger thoracostomy Catastrophic bleeding from the axilla or neck Pericardial tamponade on ultrasound or high suspicion based on injury (e.g., stab wound cardiac box)Known pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the number of patients with traumatic NCTH and class 3 hypovolemic shock attended by HEMS and transported to a participating trauma center, including the proportion of patients that successfully progress through steps 1, 2, and 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are: 1) duration of time intervals T0, T1, T6, and T7; 2) failed femoral arterial access; 3) prehospital cardiac arrest pre and post REBOA; 4) prehospital ED or operating theater resuscitative thoracotomy; 5) survival to hospital discharge; 6) ICU length or stay during primary admission; 7) hospital length of stay for primary admission; 8) mortality including cause of death; and 9) adverse events within 30 days. Additional secondary outcome measures for participants who progress to steps 2 and/or 3 are: 1) additional time intervals; 2) zone I balloon positioning in the Emergency Department (ED); 3) prehospital balloon migration; 4) prehospital or in-hospital balloon repositioning; 5) balloon reinflation or requirement for additional balloon volume; and 6) systolic blood pressure response. | — |
Countries
Netherlands
Contacts
Public ContactM.G. Van Vledder
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed