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Clinical Trials/NCT02772653
NCT02772653
Completed
Not Applicable

Evaluation of Resuscitation Markers in Trauma Patients

Andrea Campos-Serra1 site in 1 country66 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trauma
Sponsor
Andrea Campos-Serra
Enrollment
66
Locations
1
Primary Endpoint
Mortality
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Severe trauma patients have an elevated risk of multiple organ failure and death. In order to increase survival possibilities the initial treatment must be focused into resuscitation from shock. Traditionally the most common resuscitation markers used are vital signs and urine output. Unfortunately, many patients might present normal vital signs, but still undergo a compensated shock with persistent acidosis, hence being able to develop multiple organ failure and death. Consequently, it is important to define better resuscitation markers for these patients.

This investigation project consists in an observational prospective study, performed by a multidisciplinary team, in which different resuscitation markers are evaluated in severe trauma patients. There will be a specific timing (1st, 8th and 24th hours from arrival) evaluation of different markers: hemodynamic (vital signs, urine output, etc); analytical (lactate, base excess, natriuretic atrial peptide); tissue perfusion markers (NIRS); microcirculation markers (videomicroscopy) and coagulopathy markers (thromboelastometry). There will be a registry of total volume administration; blood cell transfusions and vasoactive drug requirements. Each marker will be evaluated in relation to mortality; multiple organ failure; massive transfusion protocol activation; blood cell transfusion requirement; surgical control of bleeding requirement and emergent arteriographic embolization. The objective of this study is to demonstrate which of these markers is better to predict hemodynamic evolution of severe trauma patients and might become a guide for resuscitation in the future.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
March 26, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Andrea Campos-Serra
Responsible Party
Sponsor Investigator
Principal Investigator

Andrea Campos-Serra

MD

Corporacion Parc Tauli

Eligibility Criteria

Inclusion Criteria

  • Pre-hospital Priority 0 protocol activation:
  • Glasgow coma scale \< 14
  • Systolic blood pressure \< 90 mmHg
  • Respiratory rate \< 10 or \> 29 breaths per minute
  • Absent peripheral pulses
  • Pre-hospital Priority 1 protocol activation:
  • All penetratin injuries to head, neck, torso and extremities proximal to elbow and knee
  • Flail chest
  • Two or more proximal long-bone fractures
  • Crushed, degloved or mangled extremity

Exclusion Criteria

  • Hospitalization \< 24 hours ( transport of the patient to an other trauma center)
  • Patients transported from an other hospital (first hours of medical support done elsewhere)

Outcomes

Primary Outcomes

Mortality

Time Frame: Through study completion, an average of 1-2 years

Death of the patient

Secondary Outcomes

  • Blood cell transfusion(Through study completion, an average of 1-2 years)
  • Multiple organ dysfunction (Multiple Organ Dysfunction Score)(Through study completion, an average of 1-2 years)
  • Activation of the Massive blood transfusion protocol(At hospital admission)
  • Arteriographic embolization for bleeding control(Through study completion, an average of 1-2 years)
  • Surgical intervention for bleeding control(Through study completion, an average of 1-2 years)

Study Sites (1)

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