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ACTIVE NOT RECRUITING

NCT07347652

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

Sponsor: Near East University, Turkey

View on ClinicalTrials.gov

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.

Official title: Development of a Nursing Care Protocol for the Prevention of Deep Vein Thrombosis and Its Impact on Patient Outcomes Following Cardiac Surgery

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-14

Completion Date

2026-03-28

Last Updated

2026-01-16

Healthy Volunteers

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

Interventions

DEVICE

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

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.

Inclusion Criteria:Inclusion Criteria Patients will be eligible for participation in the study if they meet all of the following criteria: 1. Adult patients aged 18 years or older. 2. 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). 3. Both male and female patients. 4. Patients admitted to the participating cardiac surgery unit during the study period. 5. 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. 6. Patients who are hemodynamically stable postoperatively and eligible to receive mechanical and/or pharmacological thromboprophylaxis. 7. Patients able to understand the study procedures and provide written informed consent (or consent obtained from a legal representative when applicable). 8. Patients expected to survive for at least three months postoperatively, allowing completion of the follow-up period. Exclusion Criteria:Exclusion Criteria Patients will be excluded from the study if they meet any of the following criteria: 1. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the previous six months. 2. Known congenital or acquired coagulation disorders, including but not limited to hemophilia, thrombophilia, or antiphospholipid syndrome. 3. Patients receiving long-term therapeutic anticoagulation (e.g., warfarin, direct oral anticoagulants) for other medical indications prior to surgery. 4. Contraindications to pharmacological thromboprophylaxis, such as: * Active bleeding * Severe thrombocytopenia (platelet count \<50,000/µL) * History of heparin-induced thrombocytopenia (HIT) 5. Contraindications to mechanical prophylaxis, including: * Severe peripheral arterial disease * Skin ulcers, infections, or recent lower-limb surgery preventing device application 6. Patients undergoing off-pump cardiac surgery or minimally invasive cardiac procedures not requiring cardiopulmonary bypass. 7. Emergency surgery requiring immediate intervention where preoperative assessment and consent cannot be obtained. 8. Pregnant or postpartum women. 9. Patients with severe renal or hepatic failure that may interfere with anticoagulant metabolism or increase bleeding risk. 10. Patients with documented malignancy under active treatment associated with a markedly elevated thrombotic risk. 11. Patients unwilling or unable to comply with the study protocol or follow-up schedule.

Locations (1)

Facility of Nursing

Nicosia, Cyprus