Traumatic Brain Injury Clinical Trial
Official title:
The Association of Norepinephrine Use in Pre-hospital Transport and Early Mortality in Hemorrhagic Shock
Verified date | January 2022 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The effect of early, prehospital norepinephrine use in patients with traumatic shock on mortality is unknown. Recent existing observational evidence from single system data (US, France, Japan) are conflicting. The investigators hypothesize that prehospital norepinephrine is associated with decreased mortality when used in patients with traumatic shock.
Status | Completed |
Enrollment | 2164 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Age 18-90 years - Blunt traumatic mechanism of injury - Admitted to the trauma center from the scene of injury - Systolic blood pressure during prehospital transport or at admission to the trauma center <100 mmHg Exclusion Criteria: - Penetrating mechanism of injury - No vital signs at the scene of injury - Prehospital cardiac arrest - Transferred to the trauma center from another hospital |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore | Beaujon Hospital, University Grenoble Alps |
Beloncle F, Meziani F, Lerolle N, Radermacher P, Asfar P. Does vasopressor therapy have an indication in hemorrhagic shock? Ann Intensive Care. 2013 May 22;3(1):13. doi: 10.1186/2110-5820-3-13. — View Citation
Gauss T, Gayat E, Harrois A, Raux M, Follin A, Daban JL, Cook F, Hamada S; TraumaBase Group; Prehospital Traumabase Group Ile de France, SAMU=Service d'Aide Médicale Urgente. Effect of early use of noradrenaline on in-hospital mortality in haemorrhagic sh — View Citation
Gupta B, Garg N, Ramachandran R. Vasopressors: Do they have any role in hemorrhagic shock? J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):3-8. doi: 10.4103/0970-9185.202185. Review. — View Citation
Harrois A, Baudry N, Huet O, Kato H, Dupic L, Lohez M, Ziol M, Vicaut E, Duranteau J. Norepinephrine Decreases Fluid Requirements and Blood Loss While Preserving Intestinal Villi Microcirculation during Fluid Resuscitation of Uncontrolled Hemorrhagic Shoc — View Citation
Sims CA, Holena D, Kim P, Pascual J, Smith B, Martin N, Seamon M, Shiroff A, Raza S, Kaplan L, Grill E, Zimmerman N, Mason C, Abella B, Reilly P. Effect of Low-Dose Supplementation of Arginine Vasopressin on Need for Blood Product Transfusions in Patients — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Early mortality | Death within 24-hours of admission to the trauma center | Admission to the trauma center to 24-hours after admission | |
Secondary | 28-day mortality | Death occurring within 28-days from admission to the trauma center | Admission to the trauma center to 28-days after admission |
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