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Clinical Trials/NCT06732726
NCT06732726RecruitingNot Applicable

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

Al-Nahrain University2 sites in 1 country150 target enrollmentStarted: April 20, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
150
Locations
2
Primary Endpoint
Incidence of Venous Thromboembolism (VTE) Episodes in Patients

Study Overview

Brief Summary

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.

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

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

  • Incidence of Symptomatic Pulmonary Embolism in Patients(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(Post-Discharge Follow-Up: Day 7, Day 15, and Day 30)

Investigators

Sponsor
Al-Nahrain University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Abdulillah R. Khamees

Principal Investigator

Al-Nahrain University

Study Sites (2)

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