- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06445283
Determination of Venous Thromboembolism Risk and Nursing Practices in Patients Hospitalized in Medical Services
June 6, 2024 updated by: Humeyra Zengin, RN,PhD, Hacettepe University
Determination of Venous Thromboembolism Risk and Nursing Practices in Patients Hospitalized in Medical Services in a Tertiary University Hospital: Point Prevalence Study
Together with individual predisposition to form vascular clots and clinical conditions that further increase this risk, venous thromboembolism (VTE) poses a significant additional morbidity and mortality risk for the majority of the world's population.
Although VTE causes serious disability and death when undiagnosed, it is a medical condition that can be prevented when diagnosed early.
Although all hospitalized patients are at risk of DVT, studies have shown that 75% of hospitalized patients are hospitalized in internal clinics.As a result of this observational study, it was aimed to determine the VTE risk levels of the patients from the time of hospitalization and to determine preventive nursing care for VTE.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Venous Thromboembolism (VTE) refers to interrelated diagnoses such as Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
10-20% of venous thromboembolic events occur in medical patients and 10-80% in intensive care patients.
Recognized as a major complication for medical and surgical patients, VTE has been described as the 'silent killer' of hospitalized patients.
During the Covid-19 pandemic in recent years, high rates of thrombolytic events have been reported in hospitalized COVID-19 patients.
Nurses have an important role in identifying risk factors for VTE, taking precautions and assessing patient compliance with these precautions.
The nurse should identify risk factors in the preoperative period, long-term and intensive care hospitalizations by taking a comprehensive history and physical assessment of the patient before hospitalization.
There are several risk assessment models developed to assess the risk of VTE for application to inpatient medical patients.
There are various risk assessment models developed for application to inpatient medical patients.
Padua and IMPROVE VTE risk assessment models are frequently used.
In the literature, it is stated that the Padua model gives moderate results and the IMPROVE model gives moderate-good results in predicting risk (1).
Therefore, risk levels were not determined with the IMPROVE risk assessment tool in this study.
Study Type
Observational
Enrollment (Actual)
157
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey
- Hacettepe Uviversity
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Ankara
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Altındağ, Ankara, Turkey
- Hacettepe University
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The population of the study will consist of patients hospitalized in the medical clinics of an Adult Hospital of a University.
The Adult Hospital serving adult patients has a capacity of 801 beds and the number of beds allocated for medical services is 211.
Description
Inclusion Criteria:
- To be conscious,
- Consent of the patient's relatives to participate in the study in unconscious patients
- 24 hours have passed since hospitalization
- The patient admitted to hospitalization has been pre-assessed by the nurse and the pre-assessment form and nurse observation form have been completed
Exclusion Criteria:
- Surgical patients
- Pregnant patients
- Refusing to participate in the study during the completion of the data collection forms.
- In unconscious patients, the patient's relatives did not give consent to participate in the study
- Unconscious patient whose relatives cannot be reached
- The patient admitted to hospitalization was not pre-assessed by the nurse and the pre-assessment form and nurse observation form were not filled out
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Determination of IMPROVE risk model risk levels according to deep vein thrombosis and pulmonary embolism risk factors
Time Frame: 21 February 2024
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IMPROVE VTE Risk modeli,the seven risk factors evaluated in this model are history of VTE, thrombophilia, cancer in remission within the last 5 years, lower extremity paralysis or paresthesia (leg falling to the bed within 5 seconds), immobilization (complete immobility in bed or chair for ≥ 1 day), ICU (ICU)/Coronary ICU hospitalization, Age ≥ 60 years.
In this model with a maximum of 12 points; 0-1 point range is defined as low VTE risk, 2-3 point range as moderate VTE risk and 4 points and above high VTE risk,
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21 February 2024
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rate of implementation of nursing practices for VTE risk
Time Frame: 21 February 2024
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Nursing Practise; Informing patients about VTE, To Mobilize the Patient Leg exercises in bed Compression Elastic Socks Intermittent Pneumatic Compression Evaluation of the lower extremities (calf pain, edema, discoloration, tenderness, temperature increase and pulse control, etc.) Daily monitoring of laboratory tests Evaluation of the Glasgow Coma Scale
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21 February 2024
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Humeyra Zengin, Director of Nursing Services
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)
February 21, 2024
Primary Completion (Actual)
February 21, 2024
Study Completion (Actual)
February 21, 2024
Study Registration Dates
First Submitted
May 31, 2024
First Submitted That Met QC Criteria
May 31, 2024
First Posted (Actual)
June 6, 2024
Study Record Updates
Last Update Posted (Actual)
June 10, 2024
Last Update Submitted That Met QC Criteria
June 6, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HU-NS-VTERisk001
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.
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