Independent Predictors of Mortality in Polytrauma Patients

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01669577
First received: August 8, 2012
Last updated: January 8, 2015
Last verified: January 2015
  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 University of Sao Paulo:

Primary Outcome Measures:
  • Death [ Time Frame: Within the first 30 days ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 8, 2012
Results First Received: December 24, 2014
Last Updated: January 8, 2015
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
predictors
trauma
mortality

Additional relevant MeSH terms:
Multiple Trauma
Wounds and Injuries

ClinicalTrials.gov processed this record on July 30, 2015