Evaluation of Thromboprophylaxis Appropriateness in Hospitalized Medical Patients

Sponsor

Al-Esraa University College (Other)

Overall Status

Recruiting

CT.gov ID

NCT05449808

Collaborator

(none)

320

Enrollment

Location

3.6

Anticipated Duration (Months)

88.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Considering observational studies that suggested a relationship between acutely ill medical patients and venous thromboembolism (VTE), interventional studies with anticoagulant medications indicated a marked decline in VTE during and after hospitalization. Despite the therapeutic value of lowering this result, there is a low inclination to utilize anticoagulants in patients hospitalized for acute medical diseases. This observational research aims to assess the appropriateness of venous thromboprophylaxis offered to patients admitted to internal medicine wards.

Condition or Disease	Intervention/Treatment	Phase
Deep Vein Thrombosis Pulmonary Embolism Venous Thromboses

Detailed Description

Epidemiological studies have shown a significant prevalence of thromboembolism in patients admitted to medical wards.

Based on this, various clinical studies using anticoagulants such as unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), and fondaparinux to prevent thromboembolism have been conducted in patients hospitalized for acute medical illness.

Interventional studies have repeatedly shown that anticoagulant prophylaxis lowers the incidence of deep venous thrombosis (DVT), pulmonary embolism (PE), and DVT-related mortality.

These findings led to recommendations to employ anticoagulant prophylaxis in patients hospitalized for acute medical disease; yet, anticoagulant prophylaxis is often underutilized in-hospital medical wards.

This study's primary objective is to assess the adequacy of venous thromboprophylaxis delivered to medical inpatients who need pharmacologic intervention in accordance with the American College of Chest Physicians (ACCP) guideline using the Padua prediction score.

Study Design

Study Type:

Observational

Anticipated Enrollment :

320 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Evaluation of the Appropriateness of Venous Thromboprophylaxis in Hospitalized Medical Patients Employing the Padua Prediction Score: an Observational Study

Anticipated Study Start Date :

Aug 13, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

Appropriateness of venous thromboprophylaxis [August - December 2022]
The primary outcome of this study is to evaluate the appropriateness of venous thromboprophylaxis administered to medical inpatients who need pharmacologic interventions according to the American College of Chest Physicians (ACCP) 2012 guidelines and its second update in 2021.

Secondary Outcome Measures

Reasons for insufficient venous thromboprophylaxis [August - December 2022]
The secondary purpose is to explore some significant reasons for insufficient venous thromboprophylaxis in various patients, such as prescription errors and administration mistakes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥18 years
Hospitalized for any cause in the internal medicine ward
Ability to give informed consent, as informed by the physicians in charge of the patient

Exclusion Criteria:

Expected hospital stay < 48 h
Patients unable to give informed consent, as informed by the physicians in charge of the patient
Patients with therapeutic anticoagulation at hospital admission
Patients admitted for a disease requiring therapeutic anticoagulation
Patients admitted to non-medical hospital wards