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HEMOSTATİC PAD AND SANDBAG

RecruitingNAAges 18 Years - anyAllUludag University
NCT07771127 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Chitosan-Based Hemostatic Pad
  • Sandbag Application
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Where

1 site
Bursa Uludag University Hospital
Bursa, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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