Padua Prediction Score for VTE Risk in Thoracic Surgery Patients

Not yet recruiting

• Conditions: DVT - Deep Vein Thrombosis; VTE (Venous Thromboembolism)

• Registration Number: NCT06732726
• Lead Sponsor: Al-Nahrain University

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 Timeline

• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-16
• Last Update Posted: 2025-03-18
• Study Start: 2025-04-20
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Venous Thromboembolism (VTE) Episodes in Patients	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	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 Outcome Measures

Name	Time	Method
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	symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography.
Rate of Recurrent Deep Vein Thrombosis (DVT) in Patients	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).

Trial Locations

Locations (1)

College of Medicine - Al-Nahrain University; 🇮🇶 Baghdad, Kadhimiya, Iraq