Venous ThromboembolismNCT06445283
Determination of Venous Thromboembolism Risk and Nursing Practices in Patients Hospitalized in Medical Services
An observational study of Venous Thromboembolism, run by Hacettepe University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Determination of VTE risk levels
- How many people
- 157 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 21 Feb 2024to 21 Feb 2024
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Hacettepe University
Altındağ, Ankara
Hacettepe Uviversity
Ankara
About this study
Official title: 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.
Read the 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.
- Conditions
- Venous Thromboembolism
- Being tested
- Determination of VTE risk levels
- Keywords
- Venous Thromboembolism, Nursing Practise
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of VTE risk levelsOther
Determination of VTE risk levels of patients using IMPROVE risk assessment tool according to deep vein thrombosis and pulmonary embolism risk factors
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 21 February 2024
Secondary outcomes (1)
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
Measured: 21 February 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start21 Feb 2024
- Primary completion21 Feb 2024
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 157 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Humeyra Zengin, RN,PhD, Hacettepe University
- Investigators
- Humeyra Zengin, Principal investigator, Director of Nursing Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445283
- Sponsor's protocol ID
- HU-NS-VTERisk001
- Status last verified
- Jun 2024
- First submitted
- 31 May 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32273920
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Venous Thromboembolism Risk and Nursing Practices in Patients Hospitalized in Medical Services in a Tertiary University Hospital: Point Prevalence Study
- ClinicalTrials.gov ID
- NCT06445283
- Acronym / sponsor ID
- HU-NS-VTERisk001
- Conditions
- Venous Thromboembolism
- Keywords
- Venous Thromboembolism, Nursing Practise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determination of VTE risk levelsDetermination of VTE risk levels of patients using IMPROVE risk assessment tool according to deep vein thrombosis and pulmonary embolism risk factors | Other | – |
Primary outcome
Determination of IMPROVE risk model risk levels according to deep vein thrombosis and pulmonary embolism risk factors
Time frame: 21 February 2024
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,
1 secondary outcome
Rate of implementation of nursing practices for VTE risk
Time frame: 21 February 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Results publication: PubMed 32273920Skeik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Humeyra Zengin principal investigator
Director of Nursing Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Hacettepe University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of IMPROVE risk model risk levels according to deep vein thrombosis and pulmonary embolism risk factors (time frame: 21 February 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06445283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.