- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03319381
Geriatric Polytrauma SOP
October 23, 2017 updated by: University of Zurich
Implementation of New Standard Operating Procedures for Geriatric Trauma Patients With Multiple Injuries
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
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
311
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
61 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
Inclusion Criteria:
Inclusion in internal trauma database
Exclusion Criteria:
Comprised age < 65 years, ISS < 9, and transfers from other hospitals.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
w/o SOP
Time period 1: 2000-2006, without 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
In-hospital mortality
Time Frame: 30 days
|
In-hospital mortality
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Infections
Time Frame: 30 days
|
Infections
|
30 days
|
|
Rate of palliative care
Time Frame: 30 days
|
Rate of palliative care
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2000
Primary Completion (Actual)
December 31, 2012
Study Completion (Actual)
December 31, 2012
Study Registration Dates
First Submitted
October 17, 2017
First Submitted That Met QC Criteria
October 23, 2017
First Posted (Actual)
October 24, 2017
Study Record Updates
Last Update Posted (Actual)
October 24, 2017
Last Update Submitted That Met QC Criteria
October 23, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- USZ-TRA-SPRKA001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Geriatrics
-
KTO Karatay UniversityCompleted
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Universitas PadjadjaranCompletedGeriatrics RehabilitationIndonesia
-
Hospices Civils de LyonCompleted
-
Istanbul University - Cerrahpasa (IUC)Completed
-
University Hospital, LilleCompleted
-
Jewish General HospitalActive, not recruiting
-
GenfitCompleted
-
Centre Francois BaclesseCompleted
-
Centre Hospitalier Universitaire DijonWithdrawn
Clinical Trials on Following new SOPs
-
Seva Canada SocietyPragyaan Sustainable Health Outcomes Foundation; Divyajyoti Trust - Tejas Eye...Recruiting
-
Center for Sepsis Control and Care, GermanyGerman Federal Ministry of Education and ResearchCompletedSevere SepsisGermany
-
Peking University First HospitalRecruitingGestational Diabetes | Induction of Labor Affected Fetus / NewbornChina
-
University of OxfordCompleted
-
The University of Texas Health Science Center,...Not yet recruitingFetal Growth RetardationUnited States
-
GenfitNaturalpha; SGS Aster S.A.S.CompletedCardiovascular Diseases | Metabolic Diseases | Diabetes Mellitus, Type 2 | Type 2 Diabetes | Dyslipidemia | ObeseFrance
-
Assistance Publique - Hôpitaux de ParisWithdrawnThe Study Focus on no Specific ConditionFrance
-
CNR Institute of Neuroscience, ParmaHumanitas Hospital, ItalyRecruiting
-
University of MichiganChildren's Mercy Hospital Kansas CityTerminatedEnteral Nutrition | Enteral Feeding | Gastrostomy TubeUnited States