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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06445283
Other study ID # HU-NS-VTERisk001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 21, 2024
Est. completion date February 21, 2024

Study information

Verified date June 2024
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 157
Est. completion date February 21, 2024
Est. primary completion date February 21, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Determination of VTE risk levels
Determination of VTE risk levels of patients using IMPROVE risk assessment tool according to deep vein thrombosis and pulmonary embolism risk factors

Locations

Country Name City State
Turkey Hacettepe University Altindag Ankara
Turkey Hacettepe Uviversity Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Skeik N, Westergard E. Recommendations for VTE Prophylaxis in Medically Ill Patients. Ann Vasc Dis. 2020 Mar 25;13(1):38-44. doi: 10.3400/avd.ra.19-00115. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Determination of IMPROVE risk model risk levels according to deep vein thrombosis and pulmonary embolism risk factors 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, 21 February 2024
Secondary Rate of implementation of nursing practices for VTE risk 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 21 February 2024
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