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NCT Number: NCT06732726

Padua Prediction Score for VTE Risk in Thoracic Surgery Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

College of Medicine - Al-Nahrain University

Baghdad, Kadhimiya, Iraq

Location contact

Abdul-Ilah R. Khamis

PRINCIPAL_INVESTIGATOR

Ibrahim Abusufian Dafallah, MBBS

SUB_INVESTIGATOR

Mahmoud M Morsy, MD

SUB_INVESTIGATOR

Qais M. Qasim, Student

SUB_INVESTIGATOR

Sanarya N Abd-Al-Taj, Student

SUB_INVESTIGATOR

Shewaz Tariq Latif, MD

SUB_INVESTIGATOR

Zahraa Bassam Alkhalidy, Student

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Abdul-Ilah R. Khamis

CONTACT

[email protected]

+9647838571013

Sponsors and collaborators

Lead sponsor

Al-Nahrain University

Other

Registry information

Official study title

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

Acronym: DVT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2024
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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