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Not yet recruiting NCT06732726

Padua Prediction Score for VTE Risk in Thoracic Surgery Patients

— Observational DVT - Deep Vein Thrombosis VTE (Venous Thromboembolism)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: DVT - Deep Vein Thrombosis, VTE (Venous Thromboembolism). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Iraq
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Primary outcome measures

  • 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]
  • Padua Prediction Score [Time frame: Day 1 preoperative (one day prior to surgery)]
Secondary outcome measures (2)
  • 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]
  • Rate of Recurrent Deep Vein Thrombosis (DVT) in Patients [Time frame: Post-Discharge Follow-Up: Day 7, Day 15, and Day 30]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Iraq · 1 center
  • College of Medicine - Al-Nahrain University — Baghdad

Publications

  • Al Yami MS, Silva MA, Donovan JL, Kanaan AO. Venous thromboembolism prophylaxis in medically ill patients: a mixed treatment comparison meta-analysis. J Thromb Thrombolysis. 2018 Jan;45(1):36-47. doi: 10.1007/s11239-017-1562-5. PMID 29043538
  • 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. PMID 20738765

Identifiers

NCT: NCT06732726 · UNCOMIRB20241210 · 008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗