Chitosan-Based Hemostatic Pad vs Sandbag After Femoral Angiography and PCI
Official title: Comparison of Factors Related to Bleeding, Pain, Comfort Level, and Sleep Quality in Patients Undergoing Femoral Coronary Angiography Using a Chitosan-Containing Hemostatic Pad Versus a Sandbag
Run by Uludag University · NCT07771127 · Data updated 2026-11-12
This study tests whether a chitosan-based hemostatic pad can better stop bleeding and improve comfort after femoral artery access for coronary angiography or PCI, compared with a traditional sandbag method.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 480 (estimated) |
| Sponsor | Uludag University Academic / other |
| Locations | 1 site (Bursa, Nilüfer) |
| Status | Recruiting |
| Started | June 10, 2026 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT07771127 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18+ undergoing a single femoral arterial access for CAG and/or PCI with 5–7 Fr sheaths, able to consent, and without major exclusions such as shellfish allergy or active bleeding.
✕Probably not a fit
Patients with shellfish or chitosan allergies, complex or multiple access sites, high bleeding risk, or conditions leading to non-amenable hemostasis may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares two methods used to achieve hemostasis after femoral arterial access in patients undergoing coronary angiography or PCI. It aims to evaluate bleeding outcomes, pain, comfort, sleep quality, and related factors between a chitosan-based hemostatic pad and a sandbag. Eligible participants are adults 18 or older undergoing a single femoral access with 5- to 7-Fr sheaths and able to consent. Exclusion criteria include allergy to shellfish or chitosan, certain medications, uncontrolled blood pressure, bleeding disorders, severe organ failure, pregnancy, and malignancy history. The study is led by Uludag University at Bursa Uludag University Hospital in Turkey.
Why it matters
Potential benefit: If successful, patients may experience faster hemostasis, less pain, improved comfort and sleep after the procedure, and reduced complication risk at the femoral access site.
How similar studies have gone: Prior research has explored hemostatic pads and mechanical compression after catheterization, with mixed results and ongoing evaluation of new materials like chitosan.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Bursa Uludag University Hospital
Bursa, Nilüfer, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Yeliz Sapulu Alakan
- Email: yelizsapulu@uludag.edu.tr
- Phone: 90 505 850 0222
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.