NCT03319381

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
311

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

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

January 1, 2000

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2012

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

13 years

First QC Date

October 17, 2017

Last Update Submit

October 23, 2017

Conditions

Geriatrics

Keywords

AlgorithmIn-hospital mortalityMultiple traumaStandard of care

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

    In-hospital mortality

    30 days

Secondary Outcomes (2)

  • Infections

    30 days

  • Rate of palliative care

    30 days

Study Arms (2)

w/o SOP

Time period 1: 2000-2006, without new SOPs

Behavioral: Following new SOPs

SOP

Time period 2: 2010-2012, after implementation of the new SOPs

Behavioral: Following new SOPs

Interventions

Following new SOPsBEHAVIORAL

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

SOPw/o SOP

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31856739DERIVED

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 24, 2017

Study Start

January 1, 2000

Primary Completion

December 31, 2012

Study Completion

December 31, 2012

Last Updated

October 24, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share