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Independent Predictors of Mortality in Polytrauma Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01669577
First Posted: August 21, 2012
Last Update Posted: January 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Luiz Guilherme Villares da Costa, University of Sao Paulo
  Purpose
Prospective observational trial searching for independent predictors of mortality. Data was collected at trauma scene, ER, three and 24 hours of hospital stay.The patients will be followed for 30 days after hospital admission.

Condition Intervention Phase
Multiple Trauma Procedure: analysis of blood samples and clinical features Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Independent Predictors of Mortality in Polytrauma Patients: a Prospective, Observational, Longitudinal Study

Resource links provided by NLM:


Further study details as provided by Luiz Guilherme Villares da Costa, University of Sao Paulo:

Primary Outcome Measures:
  • Death [ Time Frame: Within the first 30 days ]
    30 days after trauma mortality evaluation


Enrollment: 200
Study Start Date: October 2010
Study Completion Date: August 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
severe trauma patients
analysis of blood samples and clinical features
Procedure: analysis of blood samples and clinical features
clinical follow up and biochemical analysis blood at 4 time points:1-prehospital; 2-emergency room; 3- surgical center; 4-intensive care unit . 30 days follow up

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Severe trauma patients evaluated at trauma scene
Criteria

Inclusion Criteria:

  • severe trauma (ISS - Injury Severity Score- >15)

Exclusion Criteria:

  • under 18 years old patient,
  • technical problems during rescue maneuvers,
  • impossibility of blood sample draw during rescue
  • informed consent not provided
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669577


Locations
Brazil
Instituto Central do Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Luiz G Costa, MD Hospital das Clínicas da Universidade de São Paulo
  More Information

Responsible Party: Luiz Guilherme Villares da Costa, Anesthesia division clinical staff physician, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01669577     History of Changes
Other Study ID Numbers: 1081/09
First Submitted: August 8, 2012
First Posted: August 21, 2012
Results First Submitted: December 24, 2014
Results First Posted: January 9, 2015
Last Update Posted: January 9, 2015
Last Verified: January 2015

Keywords provided by Luiz Guilherme Villares da Costa, University of Sao Paulo:
predictors
trauma
mortality

Additional relevant MeSH terms:
Multiple Trauma
Wounds and Injuries