Early Norepinephrine in Trauma Patients With Hemorrhagic Shock (NCT06977659) | Clinical Trial Compass
By InvitationPhase 1/2
Early Norepinephrine in Trauma Patients With Hemorrhagic Shock
Thailand40 participantsStarted 2025-05-20
Plain-language summary
The goal of this clinical trial is to learn if norepinephrine works to treat trauma patients with hemorrhagic shock. It will also learn about the safety of norepinephrine. The main questions it aims to answer are:
Does norepinephrine affect the short-term mortality (24-hour mortality)? Does norepinephrine affect the long-term mortality (30-day mortality), survival with favorable outcome, total volume of blood product and crystalloid given in 24 hours, estimated blood loss within 24 hours, resuscitation-related complications, and length of ICU and hospital stay? What medical problems do participants have when receiving norepinephrine? Researchers will compare norepinephrine to a placebo (a look-alike substance that contains no drug) to see if norepinephrine works to treat trauma patients with hemorrhagic shock.
Participants will:
Receive norepinephrine or a placebo intravenously within 1 hour after randomization, infused for 24 hours after randomization, and then discontinued.
Patients are monitored for outcomes and adverse events.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Adult trauma patients aged 18 to 65 years
✓. Significant bleeding from traumatic events including
✓. Exsanguinous external bleeding (500 ml or more), or
✓. Evidence of internal bleeding (e.g., FAST positive, hemothorax, or bleeding seen on CT scan)
✓. Hemorrhagic shock is defined as:
✓. Hypotensive event suspected from hemorrhagic shock, characterized by
✓. Signs of shock, including:
Exclusion criteria
✕. Prehospital cardiopulmonary resuscitation or cardiopulmonary resuscitation at the trauma bay.
✕. Persistent shock for more than 12 hours prior to randomization.
✕. Severe traumatic brain injury with Glasgow Coma Scale (GCS) score less than 9 (GCS 3-8)
What they're measuring
1
24-hour mortality
Timeframe: From enrollment to the end of treatment at 24 hour
✕. A history of limb ischemia, chronic heart disease, chronic lung disease, or chronic renal disease
✕. Pregnant patients
✕. Documented "Do Not Resuscitate" (DNR) order or who declined life-sustaining intervention before randomization
✕. Allergic to norepinephrine or contraindications for its use (e.g., peripheral vascular thrombosis, mesenteric thrombosis, and fatal tachyarrhythmia)