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

NCT06729021 | Recruiting DMC

• 1 other identifier: UNCOMIRB20241207
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

DVT - Deep Vein Thrombosis

Keywords

Caprini Score; D-Dimer; DVT

Outcome Measures

Primary Outcomes (3)

• any episode of VTE (Venous Thromboembolism)

  symptomatic or asymptomatic, confirmed by instrumental diagnostics.

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

• 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)

  Day 1 preoperative (one day prior to surgery)

• Concentration of D-dimer in Blood Samples

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

  Day 1 postoperative (the first day after surgery)

Secondary Outcomes (2)

• Number of Participants with Symptomatic Pulmonary Embolism

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

• Recurrent Deep Vein Thrombosis (DVT)

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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Nahrain University: lead

Study Sites (1)

College of Medicine - Al-Nahrain University

Baghdad, Iraq

RECRUITING

Related Publications (16)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29096812 BACKGROUND

• 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.

  PMID: 15900257 BACKGROUND

• 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.

  PMID: 33984268 BACKGROUND

• 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.

  RESULT

• 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.

  PMID: 35027972 RESULT

• 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

  RESULT

• 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.

  PMID: 18278191 RESULT

• 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.

  PMID: 33363402 RESULT

• 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.

  PMID: 35041203 RESULT

• 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.

  PMID: 31596449 RESULT

• 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.

  PMID: 19959589 RESULT

• 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.

  PMID: 32082717 RESULT

• 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.

  PMID: 31706868 RESULT

• DeLaria GA, Hunter JA. Deep venous thrombosis. Implications after open heart surgery. Chest. 1991 Feb;99(2):284-8. doi: 10.1378/chest.99.2.284.

  PMID: 1989784 RESULT

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Yaser aamer Eisa Alhaibi, Assistant professor

  College Of Medicine - Nahrain University

  STUDY DIRECTOR

Central Study Contacts

Abdul-Ilah R. Khamis

CONTACT

+9647838571013; allaabed987@ced.nahrainuniv.edu.iq

Luma K Mohammed, MBChB,FIBMS/CM

CONTACT

+964770225676; lumakmohammed@nahrainuniv.edu.iq

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 11, 2024
• Study Start: January 20, 2025
• Primary Completion: July 20, 2025
• Study Completion: July 30, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)