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NCT Number: NCT06729021

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

College of Medicine - Al-Nahrain University

Baghdad, Iraq

Location status: Recruiting

Location contact

Abdul-Ilah R. Khamis

CONTACT

[email protected]

+9647838571013

Abdul-Ilah R. Khamis

PRINCIPAL_INVESTIGATOR

Luma K Mohammed, MBChB,FIBMS/CM

CONTACT

[email protected]

+964770225676

Mahmoud M Morsy, MD

SUB_INVESTIGATOR

Mustafa Mohammed Ahmed, Student

SUB_INVESTIGATOR

Nada Ali Omar, MBBS

SUB_INVESTIGATOR

Nino Dekanoidze MD

SUB_INVESTIGATOR

Saja J. Abotaleb, M.B.CH.B

SUB_INVESTIGATOR

Salaheddin M. Abdulhamid, MBBS

SUB_INVESTIGATOR

Sarah H. Al-Dlo, Student

SUB_INVESTIGATOR

Zahraa Bassam Alkhalidy, Student

SUB_INVESTIGATOR

Zaid Salwan Akram, Student

SUB_INVESTIGATOR

About this study

Research indicates that the incidence of deep vein thrombosis (DVT) among surgical patients is notably higher than in the general population. In a review of 10,638 cardiac surgical patients, the incidence of deep vein thrombosis (DVT) was found to be 0.7% due to multiple factors, including prolonged immobility, the hypercoagulable state induced by surgical interventions, and vascular trauma associated with cardiothoracic procedures. Patients undergoing cardiac surgery may have longer hospital stays, which correlates with increased risk for deep vein thrombosis (DVT). For instance, studies indicate that the incidence of deep vein thrombosis (DVT) in patients post-cardiac surgery can be as high as 1.62%. Certain surgeries, such as coronary artery bypass grafting (CABG) and valve surgeries, have shown a higher incidence of deep vein thrombosis (DVT) compared to other surgical procedures. For example, one study found that 1.62% of patients developed deep vein thrombosis (DVT) after cardiac surgery. Procedures like thoracotomy or pneumonectomy are associated with even higher risks due to the extensive surgical trauma involved. Research has indicated that patients undergoing such surgeries may experience DVT rates as high as 34.1%.

Lower extremity venous thrombosis (LEVT) is a significant clinical concern that encompasses deep vein thrombosis (DVT) and pulmonary embolism (PE) and poses a considerable risk postoperatively. The risk of PE is especially pronounced during the first six weeks post-surgery, with studies indicating that patients are up to 70 times more likely to experience VTE during this period compared to those who have not undergone surgery The risk remains elevated beyond six weeks, albeit at a reduced level. For instance, the odds ratio for PE between weeks 7 and 12 post-surgery can be as high as 4.23 for certain surgical types. This condition represents a continuum of pathology that can lead to severe outcomes, including sudden death from PE, This is considered one of the more serious postoperative complications. Early identification and the timely use of preventive measures can prevent PE and other fatal complications.

The extensive research currently conducted on the risk factors for postoperative VTE has yielded several risk assessment models. The Caprini score is widely used across various surgical specialties to identify patients at high risk of developing VTE. Among these, the modified Caprini score is the most commonly used tool in the thoracic surgery department. D-dimer is a biomarker of fibrin formation and degradation and acts a marker of coagulation and fibrinolysis system activation. As an indirect marker of thrombosis activity, D-dimer is of great significance for checking the formation of acute venous thrombosis. Although D-dimer has high negative predictive value for DVT, it has low positive predictive value and low specificity for thrombosis The Caprini score has been validated across numerous specialties in Iraq, confirming its reliability as a predictive tool for VTE. Many hospitals in Iraq lack modern medical equipment and resources that are essential for diagnosing and treating VTE effectively. This deficiency contributes to a reliance on outdated practices and guidelines, which may not align with current best practices in VTE management The slow adoption of new technologies impedes the ability to perform accurate risk assessments and implement evidence-based protocols for VTE prophylaxis. For instance, studies indicate that healthcare providers often depend on clinical experience rather than established guidelines due to a lack of access to updated resources The aim of this study is to bridge these gaps by investigating the efficacy of using a combined approach involving the modified Caprini risk assessment score and D-dimer testing values in patients with lower extremity venous thrombosis following cardiothoracic surgery We hypothesized that the combination of these two indicators may provide better predictive value. These findings may provide the basis for the follow-up prediction and timely intervention of high-risk groups of post-surgery patients, potentially leading to better patient outcomes. This combination approach has been explored in several international studies, but its application within Iraq, specifically in Baghdad, has yet to be thoroughly examined in cardiothoracic patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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: 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.
  • Incomplete Data: missing essential clinical or laboratory data for Modified Caprini Score calculation or D-Dimer measurement.
  • Pregnancy: pregnant women or those within six weeks postpartum.
  • Noncompliance: Patients unwilling or unable to adhere to study follow-up protocols.

Treatment and study plan

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

Primary outcomes

  1. any episode of VTE (Venous Thromboembolism)

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

    symptomatic or asymptomatic, confirmed by instrumental diagnostics.

  2. Caprini risk assessment model scores

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

    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)

  3. Concentration of D-dimer in Blood Samples

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

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

Secondary outcomes

  1. Number of Participants with Symptomatic Pulmonary Embolism

    Time frame: In-Hospital Phase (average of 7 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.

  2. Recurrent Deep Vein Thrombosis (DVT)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Abdul-Ilah R. Khamis

CONTACT

[email protected]

+9647838571013

Luma K Mohammed, MBChB,FIBMS/CM

CONTACT

[email protected]

+964770225676

Sponsors and collaborators

Lead sponsor

Al-Nahrain University

Other

Registry information

Official study title

Predictive Efficacy of Modified Caprini Score and D-Dimer for the Evaluation and Management of Lower Extremity Venous Thrombosis Among Cardiothoracic Surgery Patients in Baghdad

Acronym: DVT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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