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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05175872
Other study ID # 928
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 14, 2019
Est. completion date October 15, 2021

Study information

Verified date December 2021
Source Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Trauma is an important health problem that causes increased morbidity and mortality. Most of the patients are taken into intensive care and followed up in intensive care with severe and multitrauma and constitute an important part of the critical diseases followed in the intensive care unit. At the same time, these fatal injuries cause a serious public health problem both economically and socially. According to World Health Organization data, 5.8 million people die each year due to trauma. Trauma is seen more frequently at a young age and the most common cause is motor vehicle accidents and it is the first cause of death between 1-44 years. There is a strong relationship between deaths caused by trauma and factors such as age, gender, cause of trauma, and trauma area. In addition, the duration of ICU and mechanical ventilator stay, supportive treatments, trauma scores, and scores such as APACHE 2 and SOFA routinely used in intensive care have been shown to be strongly associated with mortality. Therefore, the demographic data, trauma scores, mechanical ventilator requirement, renal failure, inotropic need, intensive care scores such as APACHE 2, SOFA, re-operation, re-operation, intensive care stay, blood replacement need, wound infection and morbidity and mortality in trauma patients will be effective.


Recruitment information / eligibility

Status Completed
Enrollment 194
Est. completion date October 15, 2021
Est. primary completion date October 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Patients under the age of 18 - Patients who refused to participate in the study - Non-traumatic patients

Study Design


Locations

Country Name City State
Turkey Okmeydani Education and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Surgical Apgar Score Surgical Apgar Score (SAS) is used for predicting the occurrence of major postoperative morbidities and mortality after general and vascular surgery. SAS is a 10-point score based on 3 easily obtained parameters: the estimated blood loss, lowest heart rate, and lowest mean arterial pressure during surgery during the procedure
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