Evaluation of Thromboprophylaxis Appropriateness in Hospitalized Medical Patients

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05449808
• Other study ID #: Venous thromboprophylaxis
• Status: Recruiting
• Start date: November 13, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: October 2022
• Source: Al-Esraa University College
• Contact: Laith G. Shareef, F.I.B.M.S.
• Phone: 009647702884263
• Email: laith-shareef[@]esraa.edu.iq
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thromboses
• Venous Thrombosis

Locations

Country	Name	City	State
Iraq	EUC	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
Al-Esraa University College

Country where clinical trial is conducted

Iraq, 

References & Publications (2)

Barbar S, Noventa F, Rossetto V, Ferrari A, Brandolin B, Perlati M, De Bon E, Tormene D, Pagnan A, Prandoni P. A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score. J Thromb Haemost. 2010 Nov;8(11):2450-7. doi: 10.1111/j.1538-7836.2010.04044.x. — View Citation

Haas SK. Venous thromboembolic risk and its prevention in hospitalized medical patients. Semin Thromb Hemost. 2002 Dec;28(6):577-84. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appropriateness of venous thromboprophylaxis	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.	August - December 2022
Secondary	Reasons for insufficient venous thromboprophylaxis	The secondary purpose is to explore some significant reasons for insufficient venous thromboprophylaxis in various patients, such as prescription errors and administration mistakes.	August - December 2022