This Research Proposal Focuses on Evaluating the Effectiveness of a Nursing Care Protocol in Preventing Deep Vein Thrombosis (DVT) in Patients Undergoing On-pump Cardiac Surgery. The Study Will Include an Intervention Group That Receives the Nursing Protocol and a Control Group That Receives Routine

NCT07347652 | Active Not Recruiting DMC

• 1 other identifier: NEU\2025\138-2044
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The primary focus of this research proposal is to examine the efficacy of a nursing care protocol in preventing the occurrence of deep vein thrombosis (DVT) in patients undergoing on-pump cardiac surgery. The investigation will encompass an experimental group that will be subjected to a specific intervention, alongside a control group that will adhere to conventional care procedures. The central objective is to exhibit a statistically significant decrease in the incidence of DVT within the experimental group in comparison to the control group. The secondary outcomes involve assessing the severity of DVT instances and the development of associated complications. The proposed research strategy entails delineating the criteria for selecting participants, outlining methodologies for gathering data, and detailing statistical approaches for analysis. The amassed data will undergo scrutiny through suitable statistical examinations, including chi-square tests, t-tests, or Mann-Whitney U tests, as well as logistic regression analysis. The process of data analysis will involve descriptive statistics, comparative assessments, regression analysis, and subgroup scrutiny. The interpretation of outcomes will be contextualized within the framework of the research objectives and pre-existing scientific knowledge. The ultimate objective of this study is to enhance the existing understanding of DVT prevention, provide clinically grounded recommendations supported by evidence, and elevate the quality and safety of patient care.

Conditions

On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications; DVT - Deep Vein Thrombosis; DVT Prophylaxis; DVT Prevention; Cardiac On-pump Surgery; Nursing Care Protocol

Keywords

DVT; NCP; CPS

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the incidence of symptomatic or confirmed deep-vein thrombosis (DVT) and/or pulmonary embolism (PE) within the 3-month follow-up period. Secondary endpoints include: adherence to the prophylaxis protocol, occurrence of prophylaxis

  3 MUNTHS

Study Arms (1)

Nursing Care Protocol The nursing care protocol designed for this study is a structured, evidence-ba

EXPERIMENTAL

Nursing Care Protocol The nursing care protocol designed for this study is a structured, evidence-based guideline specifically tailored for on-pump cardiac surgery patients. It differs from existing DVT prevention protocols by integrating four core components: individualized risk stratification (using Padua and Caprini scores), combined pharmacological and mechanical prophylaxis, an early mobilization regimen adapted to post-cardiac surgery tolerance, and a structured patient education component. Unlike generic thromboprophylaxis guidelines, this protocol standardizes nursing-led interventions and monitoring across preoperative, intraoperative, and postoperative stages. Follow-Up Schedule and Time-Points Follow-Up Time-Points: * Day 0 (Start of prophylaxis / Baseline) * Day 3 (Early in-hospital monitoring) * Day 7 (or just before discharge) * Week 2 (Outpatient follow-up) * Month 3 (Long-term follow-up)

Device: IPC devices facilitate venous return by simulating the physiological effects of muscle contraction, reducing venous stasis.

Interventions

IPC devices facilitate venous return by simulating the physiological effects of muscle contraction, reducing venous stasis. DEVICE

Padua Prediction Score is a clinical tool that has been validated and created to identify hospitalized medical patients who are at risk of developing Venous Thromboembolism (VTE). Caprini's Risk Assessment Model (RAM) is one of the preferred risk scoring systems for assessing VTE chances for surgery patients. Joseph A. Caprini introduced it, which combines the hereditary and environmental risk factors, with a total of more than 40 different variables used in the assessment such as age, body mass index, past occurrence of VTE, varicose veins, presence of cancer, hormone therapy, and the length of immobility. The resulting score then puts patients into risk categories of very low with 0 points, low with 1-2 points, moderate with 3-4 pts., and high with ≥5 points.

Also known as: Anticoagulant therapy reduces the likelihood of clot formation in high-risk individuals by inhibiting thrombus development., Early identification of at-risk patients enables proactive preventive strategies, reducing the likelihood of complications., Ambulation stimulates circulation and prevents venous stasis, a primary risk factor for DVT., Proper hydration reduces blood viscosity, which helps prevent thrombosis., Awareness empowers patients to recognize early warning signs and seek medical attention promptly., Accurate record-keeping ensures continuity of care and facilitates early identification of potential complications.

Nursing Care Protocol The nursing care protocol designed for this study is a structured, evidence-ba

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be eligible for participation in the study if they meet all of the following criteria:
• Adult patients aged 18 years or older.
• Patients scheduled to undergo elective or urgent on-pump cardiac surgery using cardiopulmonary bypass (e.g., coronary artery bypass grafting, valve replacement or repair, or combined procedures).
• Both male and female patients.
• Patients admitted to the participating cardiac surgery unit during the study period.
• Patients with no evidence of preoperative deep vein thrombosis (DVT) or pulmonary embolism (PE) as confirmed by clinical assessment and/or Doppler ultrasonography when indicated.
• Patients who are hemodynamically stable postoperatively and eligible to receive mechanical and/or pharmacological thromboprophylaxis.
• Patients able to understand the study procedures and provide written informed consent (or consent obtained from a legal representative when applicable).
• Patients expected to survive for at least three months postoperatively, allowing completion of the follow-up period.

You may not qualify if:

• Patients will be excluded from the study if they meet any of the following criteria:
• History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the previous six months.
• Known congenital or acquired coagulation disorders, including but not limited to hemophilia, thrombophilia, or antiphospholipid syndrome.
• Patients receiving long-term therapeutic anticoagulation (e.g., warfarin, direct oral anticoagulants) for other medical indications prior to surgery.
• Contraindications to pharmacological thromboprophylaxis, such as:
• Active bleeding
• Severe thrombocytopenia (platelet count \<50,000/µL)
• History of heparin-induced thrombocytopenia (HIT)
• Contraindications to mechanical prophylaxis, including:
• Severe peripheral arterial disease
• Skin ulcers, infections, or recent lower-limb surgery preventing device application
• Patients undergoing off-pump cardiac surgery or minimally invasive cardiac procedures not requiring cardiopulmonary bypass.
• Emergency surgery requiring immediate intervention where preoperative assessment and consent cannot be obtained.
• Pregnant or postpartum women.
• Patients with severe renal or hepatic failure that may interfere with anticoagulant metabolism or increase bleeding risk.

Sponsors & Collaborators

• Near East University, Turkey: lead
• Al-Ahli Hospital, Hebron: collaborator

Study Sites (1)

Facility of Nursing

Nicosia, Cyprus

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Development of a Nursing Care Protocol for the Prevention of Deep Vein Thrombosis and Its Impact on Patient Outcomes Following Cardiac Surgery

Model Details: Experimental Group,Justification: The experimental group will receive a specific intervention aimed at preventing deep vein thrombosis (DVT) in on-pump cardiac surgery patients. * Sample Selection: Participants will be selected from a specific hospital or clinical setting based on predetermined inclusion and exclusion criteria. * Source of Sample: Patients admitted to the participating hospital or clinical setting for on-pump cardiac surgery.Control Group,Justification: The control group will serve as a comparison to evaluate the effectiveness of the intervention by comparing the occurrence of DVT in this group.

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 16, 2026
• Study Start: June 14, 2025
• Primary Completion: December 25, 2025
• Study Completion: March 28, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

CY (1)