GeriatricsNCT03319381
Geriatric Polytrauma SOP
An observational study of Geriatrics, run by University of Zurich.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatrics
- What is being tested?
- Following new SOPs
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 311 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 31 Dec 2012
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
None listed.
Who cannot join
- Comprised age < 65 years, ISS < 9, and transfers from other hospitals.
About this study
Official title: 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
Read the 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.
- Conditions
- Geriatrics
- Being tested
- Following new SOPs
- Keywords
- Algorithm, In-hospital mortality, Multiple trauma, Standard of care
- Medical subject headings
- Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Following new SOPsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| w/o SOP | Time period 1: 2000-2006, without new SOPs Receives: Behavioral: Following new SOPs | |
| SOP | Time period 2: 2010-2012, after implementation of the new SOPs Receives: Behavioral: Following new SOPs |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
In-hospital mortality
Measured: 30 days
Secondary outcomes (2)
Infections
Infections
Measured: 30 days
Rate of palliative care
Rate of palliative care
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start1 Jan 2000
- Primary completion31 Dec 2012
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GeriatricsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 311 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319381
- Sponsor's protocol ID
- USZ-TRA-SPRKA001
- Status last verified
- Oct 2017
- First submitted
- 17 Oct 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peterer L, Ossendorf C, Jensen KO, Osterhoff G, Mica L, Seifert B, Werner CML, Simmen HP, Pape HC, Sprengel K. Implementation of new standard operating procedures for geriatric trauma patients with multiple injuries: a single level I trauma centre study. BMC Geriatr. 2019 Dec 19;19(1):359. doi: 10.1186/s12877-019-1380-z.
PubMed 31856739
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of New Standard Operating Procedures for Geriatric Trauma Patients With Multiple Injuries
- ClinicalTrials.gov ID
- NCT03319381
- Acronym / sponsor ID
- USZ-TRA-SPRKA001
- Conditions
- Geriatrics
- Keywords
- Algorithm, In-hospital mortality, Multiple trauma, Standard of care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| w/o SOP | – | Behavioral: Following new SOPsTime period 1: 2000-2006, without new SOPs |
| SOP | – | Behavioral: Following new SOPsTime period 2: 2010-2012, after implementation of the new SOPs |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Comprised age < 65 years, ISS < 9, and transfers from other hospitals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Following new SOPsThe 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 | Behavioural | SOP, w/o SOP |
Primary outcome
In-hospital mortality
Time frame: 30 days
In-hospital mortality
2 secondary outcomes
Infections
Time frame: 30 days
Rate of palliative care
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Derived from this study: PubMed 31856739Peterer L, Ossendorf C, Jensen KO, Osterhoff G, Mica L, Seifert B, Werner CML, Simmen HP, Pape HC, Sprengel K. Implementation of new standard operating procedures for geriatric trauma patients with multiple injuries: a single level I trauma centre study. BMC Geriatr. 2019 Dec 19;19(1):359. doi: 10.1186/s12877-019-1380-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatrics, run by University of Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03319381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.