This Research Proposal Focuses on Evaluating the Effectiveness of a Nursing Care Protocol in Prev… (NCT07347652) | Clinical Trial Compass
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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
Cyprus67 participantsStarted 2025-06-14
Plain-language 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.
Who can participate
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Inclusion 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.
Exclusion criteria
✕. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the previous six months.
What they're measuring
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
✕. 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:
✕. Contraindications to mechanical prophylaxis, including:
✕. 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.