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DVT - Deep Vein ThrombosisDVTNCT06729021

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

An observational study of DVT - Deep Vein Thrombosis, run by Al-Nahrain University at 1 site in Iraq.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
DVT - Deep Vein Thrombosis
What is being tested?
GCS and LMWH
Type of treatment
Medical device
How many people
112 participants
Where
1 siteIraq
Study dates
20 Jan 2025to 30 Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study 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).

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Luma K Mohammed, MBChB,FIBMS/CM contact

+964770225676

lumakmohammed@nahrainuniv.edu.iq

Iraq1 site, 1 recruiting
  • College of Medicine - Al-Nahrain University

    Baghdad

    Abdul-Ilah R. Khamis, +9647838571013, allaabed987@ced.nahrainuniv.edu.iq

    Luma K Mohammed, MBChB,FIBMS/CM, +964770225676, lumakmohammed@nahrainuniv.edu.iq

    Recruiting

Other trials in Iraq

About this study

Official 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

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?

Read more

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.

Read the detailed description

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.

Being tested
GCS, LMWH
Keywords
Caprini Score, D-Dimer, DVT
Medical subject headings
Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GCSDevice

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

  • LMWHDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. any episode of VTE (Venous Thromboembolism)

    symptomatic or asymptomatic, confirmed by instrumental diagnostics.

    Measured: 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)

    Measured: 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.

    Measured: Day 1 postoperative (the first day after surgery)

Secondary outcomes (2)
  1. Number of Participants with Symptomatic Pulmonary Embolism

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

    Measured: 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2024
  2. Study start20 Jan 2025
  3. Primary completion20 Jul 2027 (estimated)
  4. Study completion30 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06729021
Sponsor's protocol ID
UNCOMIRB20241207
Acronym
DVT
Status last verified
Sep 2026
First submitted
8 Dec 2024
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mikhael, E.M., et al., Effectiveness of Pharmacist-Led Nurse Education on Enoxaparin Injection Technique in Baghdad Teaching Hospital, Iraq. Al-Rafidain J Med Sci, 2024. 6(1): p. 202207.

  • Kareem, G.N. and S.K. Alalaf, Risk assessment and compliance with hospital guidelines for venous thromboprophylaxis after gynecological surgeries. Zanco J Med Sci, 2022. 26(2): p. 108-117.

  • Weitz JI, Fredenburgh JC, Eikelboom JW. A Test in Context: D-Dimer. J Am Coll Cardiol. 2017 Nov 7;70(19):2411-2420. doi: 10.1016/j.jacc.2017.09.024.

    PubMed 29096812
  • Caprini JA. Thrombosis risk assessment as a guide to quality patient care. Dis Mon. 2005 Feb-Mar;51(2-3):70-8. doi: 10.1016/j.disamonth.2005.02.003. No abstract available.

    PubMed 15900257
  • Khan F, Tritschler T, Kahn SR, Rodger MA. Venous thromboembolism. Lancet. 2021 Jul 3;398(10294):64-77. doi: 10.1016/S0140-6736(20)32658-1. Epub 2021 May 10.

    PubMed 33984268
  • Almurshedi, I.M.K., A.M. Kamil, and A.A. Noaman, Evaluation of Risk Factors of Venous Thromboembolism in Imam Sadiq Teaching Hospital at Babylon City. Journal of Techniques, 2022. 4(Special Issue): p. 58-63.

  • Suker SEJ, Al-Meen AAH, Khawwam AA. Assessment of knowledge and practice of venous thromboembolism (VTE) prophylaxis after cesarean section among gynecologists and obstetricians in Al-Najaf hospitals. J Med Life. 2021 Sep-Oct;14(5):690-694. doi: 10.25122/jml-2021-0226.

    PubMed 35027972
  • Alhilali, D.N., A. Tukmagi, and H.M. Abass, Venous thromboembolism risk and prophylaxis in hospitalized patients in Iraq. J Pharm Biomed Sci, 2016. 6: p. 2016

  • Stender MT, Frokjaer JB, Hagedorn Nielsen TS, Larsen TB, Lundbye-Christensen S, Elbrond H, Thorlacius-Ussing O. Combined use of clinical pre-test probability and D-dimer test in the diagnosis of preoperative deep venous thrombosis in colorectal cancer patients. Thromb Haemost. 2008 Feb;99(2):396-400. doi: 10.1160/TH07-06-0397.

    PubMed 18278191
  • Abolfotouh MA, Almadani K, Al Rowaily MA. Diagnostic Accuracy of D-Dimer Testing and the Revised Geneva Score in the Prediction of Pulmonary Embolism. Int J Gen Med. 2020 Dec 15;13:1537-1543. doi: 10.2147/IJGM.S289289. eCollection 2020.

    PubMed 33363402
  • Ke L, Cui S, Yang M, Chen J, Xu S, Jiang G, Zhang Y, Chen S, Zheng E, Zhao H, Fan X, Li Y, Zhi X, Hu B, Li H; China Embolism-Thrombosis After Surgery of Thorax (ChEST) Study Group. Validation of a modified Caprini risk assessment model in lung cancer patients undergoing surgery: Results of a multicenter cross-sectional observational study. J Surg Oncol. 2022 Apr;125(5):933-942. doi: 10.1002/jso.26794. Epub 2022 Jan 18.

    PubMed 35041203
  • Caron A, Depas N, Chazard E, Yelnik C, Jeanpierre E, Paris C, Beuscart JB, Ficheur G. Risk of Pulmonary Embolism More Than 6 Weeks After Surgery Among Cancer-Free Middle-aged Patients. JAMA Surg. 2019 Dec 1;154(12):1126-1132. doi: 10.1001/jamasurg.2019.3742.

    PubMed 31596449
  • Sweetland S, Green J, Liu B, Berrington de Gonzalez A, Canonico M, Reeves G, Beral V; Million Women Study collaborators. Duration and magnitude of the postoperative risk of venous thromboembolism in middle aged women: prospective cohort study. BMJ. 2009 Dec 3;339:b4583. doi: 10.1136/bmj.b4583.

    PubMed 19959589
  • Fei W, Jian Z, Zhi G, Rong W, Jianxin L, Yongquan G, Weiping W. Analysis of risk factors for venous thromboembolism in patients after thoracic surgery: A clinical study of 167 cases. Turk Gogus Kalp Damar Cerrahisi Derg. 2018 Jan 9;26(1):93-98. doi: 10.5606/tgkdc.dergisi.2018.14980. eCollection 2018 Jan.

    PubMed 32082717
  • Khoury H, Lyons R, Sanaiha Y, Rudasill S, Shemin RJ, Benharash P. Deep Venous Thrombosis and Pulmonary Embolism in Cardiac Surgical Patients. Ann Thorac Surg. 2020 Jun;109(6):1804-1810. doi: 10.1016/j.athoracsur.2019.09.055. Epub 2019 Nov 7.

    PubMed 31706868

Questions about this trial

What is this clinical trial studying?

An observational study of DVT - Deep Vein Thrombosis, run by Al-Nahrain University at 1 site in Iraq.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Abdul-Ilah R. Khamis (+9647838571013, allaabed987@ced.nahrainuniv.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06729021, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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