About this trial
The goal of this observational study is to evaluate the predictive efficacy of the Modified Caprini Risk Assessment Score and D-Dimer in identifying and managing lower extremity venous thrombosis (LEVT) among cardiothoracic surgery patients in Baghdad. The main questions it aims to answer are:
Does combining the Modified Caprini Score with D-Dimer improve the accuracy of predicting lower extremity venous thrombosis (LEVT) compared to using each tool independently? Can these tools effectively guide clinical decisions for lower extremity venous thrombosis (LEVT) prevention and management in this patient population?
Participants will:
Undergo risk assessment for lower extremity venous thrombosis (LEVT) using the Modified Caprini Score and have their D-Dimer levels measured during their hospital stay.
Be monitored for clinical outcomes, including confirmed lower extremity venous thrombosis (LEVT) incidence, need for anticoagulation therapy, and complications such as pulmonary embolism or recurrent thrombosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Preexisting LEVT or Pulmonary Embolism: Diagnosed before the index surgery.
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.
Trial population
The study will include adult patients (≥18 years old) undergoing cardiothoracic surgery at Kadhimiya Teaching Hospital in Baghdad, with a focus on those at risk for lower extremity venous thrombosis (LEVT).
Trial design
Cohort
Prospective
Treatments tested in this trial
GCS
DeviceGraduated compression stockings may be used after procedure by the decision of the doctor
LMWH
DrugLow-molecular-weight heparin may be used after procedure by the decision of the doctor
Treatment groups
Trial outcomes
Primary outcomes
any episode of VTE (Venous Thromboembolism)
symptomatic or asymptomatic, confirmed by instrumental diagnostics.
Caprini risk assessment model scores
rini risk assessment model scores were used to stratify patients into three groups: low risk (0-4 points), intermediate risk (5-8 points), and high risk (≥9 points)
Concentration of D-dimer in Blood Samples
The upper normal value 0.55mg/L FEU was used.
Secondary outcomes
Number of Participants with Symptomatic Pulmonary Embolism
symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography.
Recurrent Deep Vein Thrombosis (DVT)
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).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.