Evaluation of Thromboprophylaxis Appropriateness in Hospitalized Medical Patients

Recruiting

• Conditions: Deep Vein Thrombosis; Pulmonary Embolism; Venous Thromboses

• Registration Number: NCT05449808
• Lead Sponsor: Al-Esraa University College

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.

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 Timeline

• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-08
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-21
• Last Update Posted: 2022-10-24
• Study Start: 2022-11-13
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

EUC; 🇮🇶 Baghdad, Iraq