This Research Proposal Focuses on Evaluating the Effectiveness of a Nursing Care Protocol in Prev… (NCT07347652) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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.