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Geriatric Polytrauma SOP

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.
 
ClinicalTrials.gov Identifier: NCT03319381
Recruitment Status : Completed
First Posted : October 24, 2017
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
This study investigated whether there were improvements in the in-hospital mortality, infection rate, and rate of palliative care among geriatric trauma patients after the implementation of new standard operating procedures (SOPs) for the resuscitation room. These new SOPs, comprising early whole-body computed tomography (CT), damage control surgery, and the use of goal-directed coagulation management, were designed for severely injured adult trauma patients

Condition or disease Intervention/treatment
Geriatrics Behavioral: Following new SOPs

Detailed Description:
This study involved the analysis of a prospective single-centre database. Patients admitted via the resuscitation room with need for intensive care treatment after the resuscitation room phase were included and compared before the implementation of the new SOPs (between 1 January, 2000 and 31 December, 2006) and after their implementation in 2009 (between 1 January, 2010 and 31 December, 2012) of our level-I trauma centre.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 311 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Implementation of New Standard Operating Procedures for Geriatric Trauma Patients With Multiple Injuries
Actual Study Start Date : January 1, 2000
Actual Primary Completion Date : December 31, 2012
Actual Study Completion Date : December 31, 2012

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
w/o SOP
Time period 1: 2000-2006, without new SOPs
Behavioral: Following new SOPs
The new SOPs comprised early whole-body CT, damage control surgery, and the use of goal-directed coagulation management and are based on the ATLS® concept, which was the strictly followed protocol before implementation of the new SOPs

SOP
Time period 2: 2010-2012, after implementation of the new SOPs
Behavioral: Following new SOPs
The new SOPs comprised early whole-body CT, damage control surgery, and the use of goal-directed coagulation management and are based on the ATLS® concept, which was the strictly followed protocol before implementation of the new SOPs




Primary Outcome Measures :
  1. In-hospital mortality [ Time Frame: 30 days ]
    In-hospital mortality


Secondary Outcome Measures :
  1. Infections [ Time Frame: 30 days ]
    Infections

  2. Rate of palliative care [ Time Frame: 30 days ]
    Rate of palliative care



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Trauma patients admitted via the resuscitation room with need for intensive care treatment after the resuscitation room phase were included in the internal trauma database
Criteria

Inclusion Criteria:

Inclusion in internal trauma database

Exclusion Criteria:

Comprised age < 65 years, ISS < 9, and transfers from other hospitals.


Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03319381    
Other Study ID Numbers: USZ-TRA-SPRKA001
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
Algorithm
In-hospital mortality
Multiple trauma
Standard of care