NCT01669577

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
5 months until next milestone

Results Posted

Study results publicly available

January 9, 2015

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

2.7 years

First QC Date

August 8, 2012

Results QC Date

December 24, 2014

Last Update Submit

January 8, 2015

Conditions

Keywords

predictorstraumamortality

Outcome Measures

Primary Outcomes (1)

  • Death

    30 days after trauma mortality evaluation

    Within the first 30 days

Study Arms (1)

severe trauma patients

analysis of blood samples and clinical features

Procedure: analysis of blood samples and clinical features

Interventions

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

severe trauma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Severe trauma patients evaluated at trauma scene

You may qualify if:

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

You may not qualify if:

  • under 18 years old patient,
  • technical problems during rescue maneuvers,
  • impossibility of blood sample draw during rescue
  • informed consent not provided

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Central do Hospital das Clínicas da Universidade de São Paulo

São Paulo, São Paulo, 05403000, Brazil

Location

Related Publications (1)

  • da Costa LGV, Carmona MJC, Malbouisson LM, Rizoli S, Rocha-Filho JA, Cardoso RG, Auler-Junior JOC. Independent early predictors of mortality in polytrauma patients: a prospective, observational, longitudinal study. Clinics (Sao Paulo). 2017 Aug;72(8):461-468. doi: 10.6061/clinics/2017(08)02.

MeSH Terms

Conditions

Multiple TraumaWounds and Injuries

Limitations and Caveats

single center trial, majority of TBI and male patients

Results Point of Contact

Title
Luiz Guilherme Villares da Costa, MD
Organization
University of São Paulo

Study Officials

  • Luiz G Costa, MD

    Hospital das Clínicas da Universidade de São Paulo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesia division clinical staff physician

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 21, 2012

Study Start

October 1, 2010

Primary Completion

June 1, 2013

Study Completion

August 1, 2014

Last Updated

January 9, 2015

Results First Posted

January 9, 2015

Record last verified: 2015-01

Locations