Evaluation of Thromboprophylaxis Appropriateness in Hospitalized Medical Patients

October 21, 2022 updated by: Laith G. Shareef, Al-Esraa University College

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iraq
      • Baghdad, Iraq, 10011
        • Recruiting
        • EUC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Baghdad medical city; general internal medicine divisions patients'

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appropriateness of venous thromboprophylaxis
Time Frame: 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.
August - December 2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reasons for insufficient venous thromboprophylaxis
Time Frame: 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.
August - December 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Esraa University College

Investigators

  • Study Chair: Khulood M. Alsaraf, ASST PROF, Al-Esraa University College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 13, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

July 5, 2022

First Submitted That Met QC Criteria

July 7, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Actual)

October 24, 2022

Last Update Submitted That Met QC Criteria

October 21, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Venous thromboprophylaxis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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