NCT05175872

Brief Summary

In this study, the demographic and clinical characteristics of trauma patients followed up in the Intensive Care Unit of the Anesthesiology and Reanimation Clinic of the Health Sciences University Okmeydanı Training and Research Hospital for a 2-year period were evaluated prospectively to determine the morbidity and mortality rates and to determine the factors affecting these rates. data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
194

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
Last Updated

January 4, 2022

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

January 3, 2020

Last Update Submit

December 14, 2021

Conditions

Keywords

traumamortalitymorbidity

Outcome Measures

Primary Outcomes (2)

  • Injury Severity Score

    The Injury Severity Score (ISS) assesses the combined effects of the multiply-injured patients and is based on an anatomical injury severity classification. The ISS is calculated as the sum of the squares of the highest AIS code in each of the three most severely injured ISS body regions. These body regions are: * Head or neck * Face * Chest * Abdominal or pelvic contents * Extremities or pelvic girdle * External Injury Severity Scores range from 1 to 75. If an injury is assigned an AIS of 6 (identifying a currently untreatable injury), the ISS score is automatically assigned 75.

    during the procedure

  • Clinical features

    Inotropic requirement, renal failure, mechanical ventilation requirement, re-operation, need for intensive care unit, blood replacement requirement, wound infection, discharge from intensive care unit, 28-day mortality, hospital mortality, mortality, number of stay days in intensive care unit during intensive care follow-up , 20/5000 history of drug use and hospital stay days will be recorded.

    during the procedure

Secondary Outcomes (1)

  • Surgical Apgar Score

    during the procedure

Eligibility Criteria

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

All trauma patients older than 18 years of age followed up in the anesthesia and reanimation unit of the investigator's hospital with the approval of the Ethics Committee of Okmeydanı Training and Research Hospital will be included in the study.

You may qualify if:

  • Trauma Patients Followed up in the Intensive Care Unit between 14 October 2019 and 15 October 2021
  • All trauma patients over the age of 18 who signed the informed consent form and agreed to participate in the trial

You may not qualify if:

  • Patients under the age of 18
  • Patients who refused to participate in the study
  • Non-traumatic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Okmeydani Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple TraumaAccidental InjuriesWounds and Injuries

Study Officials

  • Namigar Turgut, Prof.Dr.

    Okmeydani Education and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 4, 2022

Study Start

October 14, 2019

Primary Completion

October 15, 2021

Study Completion

October 15, 2021

Last Updated

January 4, 2022

Record last verified: 2021-12

Locations