NCT06445283

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

Same day

First QC Date

May 31, 2024

Last Update Submit

June 6, 2024

Conditions

Keywords

Venous ThromboembolismNursing Practise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Rate of implementation of nursing practices for VTE risk

    21 February 2024

Interventions

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

Eligibility Criteria

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

You may qualify if:

  • To be conscious,
  • Consent of the patient's relatives to participate in the study in unconscious patients
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hacettepe University

Altındağ, Ankara, Turkey (Türkiye)

Location

Hacettepe Uviversity

Ankara, Turkey (Türkiye)

Location

Related 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.

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Humeyra Zengin

    Director of Nursing Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Nursing Services

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 6, 2024

Study Start

February 21, 2024

Primary Completion

February 21, 2024

Study Completion

February 21, 2024

Last Updated

June 10, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations