Clinical trial NCT06732726: Padua Prediction Score for VTE Risk in Thoracic Surgery Patients
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: DVT - Deep Vein Thrombosis
VTE (Venous Thromboembolism)
Keywords: Padua Prediction Score (PPS)
Lead sponsor: Al-Nahrain University
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will focus on adult patients undergoing thoracic surgery at a single center in Iraq.

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.

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.

Primary outcomes:
measure: Incidence of Venous Thromboembolism (VTE) Episodes in Patients
timeFrame: In-Hospital Phase (average of 10 days through discharge); Post-Discharge Follow-Up: Day 7, Day 15, and Day 30
measure: Padua Prediction Score
timeFrame: Day 1 preoperative (one day prior to surgery)
Secondary outcomes:
measure: Incidence of Symptomatic Pulmonary Embolism in Patients
timeFrame: In-Hospital Phase (average of 10 days through discharge); Post-Discharge Follow-Up: Day 7, Day 15, and Day 30
measure: Rate of Recurrent Deep Vein Thrombosis (DVT) in Patients
timeFrame: Post-Discharge Follow-Up: Day 7, Day 15, and Day 30
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Medicine - Al-Nahrain University
state: Kadhimiya
Study officials:
affiliation: College Of Medicine - Nahrain University
name: Yaser aamer Eisa Alhaibi, Assistant professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.