Padua Prediction Score for VTE Risk in Thoracic Surgery Patients (DVT)

March 16, 2025 updated by: Abdul-Ilah R. Khamis, Al-Nahrain University

Assessment of the Padua Prediction Score for Venous Thromboembolism Risk Stratification in Thoracic Surgery Patients: Insights From a Single-Center Cohort Study in Iraq

The goal of this observational study is to assess the predictive accuracy of the Padua Prediction Score (PPS) for venous thromboembolism (VTE) risk in thoracic surgery patients.

The study aims to answer the following question:

Does the PPS provide a more accurate prediction of VTE risk?

Participants will:

Have their VTE risk assessed using the PPS during their hospital admission.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Venous thromboembolism (VTE) is a significant cause of morbidity and mortality, comprising conditions like deep vein thrombosis (DVT) and pulmonary embolism (PE). Hospitalized patients are particularly vulnerable to VTE due to factors such as prolonged immobility, surgical procedures, and preexisting comorbidities.

To address this risk, tools like the Padua Prediction Score (PPS) have been developed. PPS is a validated scoring system that uses clinical and demographic criteria to categorize patients as high- or low-risk for VTE, allowing healthcare providers to tailor prophylactic measures accordingly. Although the Padua Prediction Score has been increasingly adopted in various healthcare settings, its applicability in Iraq remains understudied. There is limited local data on the prevalence of VTE, risk assessment practices and adherence to prophylaxis protocols, leaving a clear gap in the literature. This study aims to explore the utility and predictive accuracy of the Padua Prediction Score in the Iraqi healthcare context. By addressing this gap, the findings could help refine VTE prevention strategies, improve resource allocation, and ultimately reduce complications associated with this condition.

Study Type

Observational

Enrollment (Estimated)

150

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
    • Kadhimiya
      • Baghdad, Kadhimiya, Iraq
        • College of Medicine - Al-Nahrain University
        • Principal Investigator:
          • Abdul-Ilah R. Khamis
        • Sub-Investigator:
          • Zahraa Bassam Alkhalidy, Student
        • Sub-Investigator:
          • Mahmoud M Morsy, MD
        • Sub-Investigator:
          • Shewaz Tariq Latif, MD
        • Sub-Investigator:
          • Ibrahim Abusufian Dafallah, MBBS
        • Sub-Investigator:
          • Sanarya N Abd-Al-Taj, Student
        • Sub-Investigator:
          • Qais M. Qasim, Student

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will focus on adult patients undergoing thoracic surgery at a single center in Iraq.

Description

Inclusion Criteria:

  • Patients who have undergone preoperative Padua Prediction Score assessment.
  • Inpatients with a hospital stay over 3 days
  • Written informed consent obtained from patients or their legal guardians.
  • Availability for postoperative follow-up to assess outcomes like LEVT development or related complications.

Exclusion Criteria:

  • Preexisting LEVT or pulmonary embolism.
  • Severe Coagulopathy: Patients with inherited or acquired bleeding disorders (e.g., hemophilia, advanced liver disease).
  • receiving any anticoagulation therapy for any reason.
  • patients who did not undergo a postoperative D-dimer test.
  • Incomplete Data: missing essential clinical or laboratory data.
  • Pregnancy: pregnant women or those within six weeks postpartum.
  • Noncompliance: Patients unwilling or unable to adhere to study follow-up protocols.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Venous Thromboembolism (VTE) Episodes in Patients
Time Frame: In-Hospital Phase (average of 10 days through discharge); Post-Discharge Follow-Up: Day 7, Day 15, and Day 30
symptomatic or asymptomatic, confirmed by instrumental diagnostics.
In-Hospital Phase (average of 10 days through discharge); Post-Discharge Follow-Up: Day 7, Day 15, and Day 30
Padua Prediction Score
Time Frame: Day 1 preoperative (one day prior to surgery)
A total score that ranges from 0 to 20. 4 or higher indicates a significant likelihood of developing VTE.
Day 1 preoperative (one day prior to surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Symptomatic Pulmonary Embolism in Patients
Time Frame: In-Hospital Phase (average of 10 days through discharge); Post-Discharge Follow-Up: Day 7, Day 15, and Day 30
symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography.
In-Hospital Phase (average of 10 days through discharge); Post-Discharge Follow-Up: Day 7, Day 15, and Day 30
Rate of Recurrent Deep Vein Thrombosis (DVT) in Patients
Time Frame: Post-Discharge Follow-Up: Day 7, Day 15, and Day 30
A new episode of deep vein thrombosis occurs after the initial diagnosis with clinical symptoms (such as leg pain, swelling, redness, or tenderness) and is confirmed through instrumental diagnostics (e.g., ultrasound, CT venography, MRI).
Post-Discharge Follow-Up: Day 7, Day 15, and Day 30

Collaborators and Investigators

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

Sponsor

Al-Nahrain University

Investigators

  • Study Director: Yaser aamer Eisa Alhaibi, Assistant professor, College Of Medicine - Nahrain University

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 (Estimated)

April 20, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 10, 2024

First Posted (Actual)

December 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 16, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNCOMIRB20241210
  • 008 (Nahrain Medical Research Collective (NMRC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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