NCT07771127 HEMOSTATİC PAD AND SANDBAG

Eligibility & Interventions

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This trial targets 480 participants in total. It began in 2026-06-10 with a primary completion date of 2026-12-30.

Brief Summary

The aim of this study is to compare bleeding outcomes, pain, comfort levels, sleep quality, and associated factors among patients receiving a chitosan-based hemostatic pad versus a sandbag following femoral coronary angiography (CAG) and percutaneous coronary intervention (PCI). Femoral coronary angiography (CAG) and percutaneous coronary intervention (PCI) are widely performed procedures for the diagnosis and treatment of coronary artery disease (CAD), which remains the leading cause of mortality worldwide (Batmaz \& Cengiz, 2023; Wardiyana et al., 2024). Hemostasis following CAG and PCI is critical for preventing life-threatening complications, ensuring procedural success, and facilitating recovery. Vascular complications at the femoral arterial puncture site are among the most common adverse events associated with these procedures (Chen et al., 2021). Inadequate hemostasis may result in serious complications such as pseudoaneurysm, arteriovenous fistula, and retroperitoneal hemorrhage, all of which may pose significant risks to patient safety (Sauer et al., 2016). Effective bleeding control is particularly important in patients receiving intensive anticoagulant therapy. Following manual compression, sandbag application is commonly used to maintain hemostasis at the femoral access site. Typically, a sandbag weighing between 2.3 and 5 kilograms is placed over the puncture site, requiring patients to remain in a supine position with restricted mobility for approximately four to six hours (Batmaz \& Cengiz, 2023). Although prolonged bed rest and sandbag application contribute to hemostasis, they may also lead to adverse patient experiences, including pain, discomfort, urinary retention, restlessness, and impaired sleep quality (Batmaz \& Cengiz, 2023). Advances in medical technology have led to the development of hemostatic devices designed to rapidly control bleeding independently of the body's natural coagulation mechanisms. Among these, chitosan-based hemostatic pads, derived from crustacean shells, have attracted increasing attention. Due to their positive electrical charge, chitosan molecules attract negatively charged erythrocytes and platelets, facilitating the rapid formation of a mechanical barrier and clot within seconds (Arbel et al., 2010; Kılıç et al., 2024). Previous studies have demonstrated that chitosan-based pads may reduce manual compression time and vascular complications such as ecchymosis and hematoma (Ginanjar et al., 2018; Kılıç et al., 2024; Qian et al., 2024). Furthermore, they have been associated with improved patient comfort, earlier mobilization, and shorter hospital stays (Kılıç et al., 2024; Liu, 2025). The responsibilities of nurses following CAG and PCI extend beyond bleeding control and include comprehensive monitoring of vital signs, early detection of complications, and the promotion of patient comfort and well-being (Batmaz \& Cengiz, 2023; Rodrigues et al., 2024). While existing studies have primarily focused on the effectiveness of chitosan-based pads in reducing hematoma formation (Bektaş et al., 2017), evidence regarding their effects on broader patient-centered outcomes remains limited. Therefore, this study seeks to provide a comprehensive evaluation of chitosan-based hemostatic pads and conventional sandbag application with respect to bleeding outcomes, pain, patient comfort, and sleep quality. Accordingly, the present study aims to compare bleeding, pain, comfort levels, sleep quality, and related factors among patients undergoing femoral CAG and PCI who receive either a chitosan-based hemostatic pad or a sandbag for post-procedural hemostasis. The sample size was calculated using a power analysis based on an effect size of 0.40, a significance level of 5% (α = 0.05), and a statistical power of 80% (1-β = 0.80). According to the analysis, a total of 480 participants will be recruited, including 240 patients in the chitosan-based hemostatic pad group and 240 patients in the sandbag group.

Eligibility Criteria

Inclusion Criteria: * Patients aged 18 years and older scheduled for femoral coronary angiography (CAG) and/or percutaneous coronary intervention (PCI) * Patients undergoing a single femoral arterial access procedure * Patients with sheath size typically 5-Fr, 6-Fr, or 7-Fr * Patients who are conscious, alert, and able to communicate * Patients who voluntarily agreed to participate in the study Exclusion Criteria: * Patients with known allergy to shellfish or chitosan Patients using antihistamines, psychotropic medications, or sleep medications Patients with systolic and/or diastolic blood pressure above 150/100 mmHg Patients with known bleeding disorders (e.g., hemophilia) or active bleeding Patients with severe renal or hepatic failure Pregnant or breastfeeding patients Patients with a history of malignancy

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