Clinical trial NCT05449808: Evaluation of Thromboprophylaxis Appropriateness in Hospitalized Medical Patients
Official title: Evaluation of the Appropriateness of Venous Thromboprophylaxis in Hospitalized Medical Patients Employing the Padua Prediction Score: an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Venous Thromboses
Keywords: Padua prediction score
Pulmonary Embolism
Deep Vein Thrombosis
Venous Thromboses
Acute medical illness
Lead sponsor: Al-Esraa University College
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Baghdad medical city; general internal medicine divisions patients'

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.

Eligibility criteria: 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

Primary outcomes:
measure: Appropriateness of venous thromboprophylaxis
timeFrame: August - December 2022
Secondary outcomes:
measure: Reasons for insufficient venous thromboprophylaxis
timeFrame: August - December 2022
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: EUC
Study officials:
affiliation: Al-Esraa University College
name: Khulood M. Alsaraf, ASST PROF
role: STUDY_CHAIR
References:
citation: Haas SK. Venous thromboembolic risk and its prevention in hospitalized medical patients. Semin Thromb Hemost. 2002 Dec;28(6):577-84. doi: 10.1055/s-2002-36702.
citation: 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.