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Search / Trial NCT06977659

Early Norepinephrine in Trauma Patients With Hemorrhagic Shock

Launched by VISARAT PALITNONKIAT · May 15, 2025

Trial Information

Current as of September 08, 2025

Enrolling by invitation

Keywords

Trauma Norepinephrine Blood Transfusion

ClinConnect Summary

Study Population: Adult trauma patients with hemorrhagic shock

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...

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)

About Visarat Palitnonkiat

Visarat Palitnonkiat is a dedicated clinical trial sponsor focused on advancing medical research and enhancing patient care through innovative therapeutic solutions. With a commitment to ethical standards and rigorous scientific methodologies, the organization collaborates with healthcare professionals and institutions to design and execute clinical studies across various therapeutic areas. By prioritizing patient safety and data integrity, Visarat Palitnonkiat seeks to contribute valuable insights to the medical community, ultimately aiming to improve treatment outcomes and quality of life for patients worldwide.

Locations

Bangkok, , Thailand

Bangkok, , Thailand

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported