Early Norepinephrine in Trauma Patients With Hemorrhagic Shock

Launched by VISARAT PALITNONKIAT · May 15, 2025

Keywords

ClinConnect Summary

This study, called ENTHeS (Early Norepinephrine in Trauma Patients With Hemorrhagic Shock), asks whether giving norepinephrine early after a trauma with heavy bleeding can improve short- and longer-term survival and recovery, compared with a placebo. It involves adults aged 18 to 65 who have significant bleeding and signs of shock from a traumatic injury. Participants are randomly assigned to receive either norepinephrine (a medicine that raises blood pressure) or a placebo (a harmless fluid) through a vein for 24 hours, in addition to standard trauma care. The study is taking place in Bangkok at Ramathibodi and Siriraj Hospitals, and plans to enroll about 40 people.

If you join, you’ll be randomly put into one of the two groups within about an hour, and neither you nor your doctors will know which treatment you’re getting unless a safety issue requires it. After the 24-hour infusion, care continues with usual trauma treatment. Researchers will track outcomes such as survival at 24 hours and at 30 days, your ability to recover (measured by a standard scale), how much blood products and fluids you receive, and any safety problems. The trial is designed to learn if early norepinephrine helps improve survival and recovery after severe bleeding from trauma, while carefully monitoring for potential side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult trauma patients aged 18 to 65 years
• • 2. Significant bleeding from traumatic events including
• • 1. Exsanguinous external bleeding (500 ml or more), or
• • 2. Evidence of internal bleeding (e.g., FAST positive, hemothorax, or bleeding seen on CT scan)
• 3. Hemorrhagic shock is defined as:
• • 1. Hypotensive event suspected from hemorrhagic shock, characterized by
• • Systolic blood pressure less than 90 mmHg,
• • Mean arterial pressure less than 65 mmHg, or
• • A decrease in blood pressure from baseline more than 30 mmHg (as recorded in the trauma bay, resuscitation room of the emergency department at Ramathibodi Hospital, trauma unit at Siriraj Hospital, or trauma ward/ ICU) OR
• 2. Signs of shock, including:
• • Capillary refill time greater than 2 seconds,
• • Base excess less than -6 mEq/L,
• • Lactate level greater than 2 mmol/L)
• Exclusion Criteria:
• • 1. Prehospital cardiopulmonary resuscitation or cardiopulmonary resuscitation at the trauma bay.
• • 2. Persistent shock for more than 12 hours prior to randomization.
• • 3. Severe traumatic brain injury with Glasgow Coma Scale (GCS) score less than 9 (GCS 3-8)
• • 4. Traumatic limb injury with acute limb ischemia
• • 5. A history of limb ischemia, chronic heart disease, chronic lung disease, or chronic renal disease
• • 6. Pregnant patients
• • 7. Documented "Do Not Resuscitate" (DNR) order or who declined life-sustaining intervention before randomization
• • 8. Allergic to norepinephrine or contraindications for its use (e.g., peripheral vascular thrombosis, mesenteric thrombosis, and fatal tachyarrhythmia)
• • 9. Current use of ergotamine, monoamine oxidase inhibitors (MAOIs), or tricyclic antidepressants (TCAs)
• • 10. Prior vasopressor administration before randomization.
• • 11. Weight less than 30 kilograms (Extremely low body weight may increases the risk of weight-based dosing issues)