Predictive Value of Modified Caprini Score and D-Dimer in Managing Lower Limb Venous Thrombosis in Cardiothoracic Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAl-Nahrain University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • GCS

    Device

    Graduated compression stockings may be used after procedure by the decision of the doctor

  • LMWH

    Drug

    Low-molecular-weight heparin may be used after procedure by the decision of the doctor

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

any episode of VTE (Venous Thromboembolism)

symptomatic or asymptomatic, confirmed by instrumental diagnostics.

Time frame
In-Hospital Phase (average of 7 days through discharge); Post-Discharge Follow-Up: Day 7, Day 15, and Day 30
2

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)

Time frame
Day 1 preoperative (one day prior to surgery)
3

Concentration of D-dimer in Blood Samples

The upper normal value 0.55mg/L FEU was used.

Time frame
Day 1 postoperative (the first day after surgery)

Secondary outcomes

1

Number of Participants with Symptomatic Pulmonary Embolism

symptomatic pulmonary embolism confirmed by perfusion isotope scanning or CT pulmonary angiography.

Time frame
In-Hospital Phase (average of 7 days through discharge); Post-Discharge Follow-Up: Day 7, Day 15, and Day 30
2

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).

Time frame
Post-Discharge Follow-Up: Day 7, Day 15, and Day 30

Other outcomes

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