The transradial approach (TRA) has emerged as the gold standard for diagnostic and interventional cardiovascular procedures due to its superior safety profile, reduced bleeding complications, shorter recovery times, and improved patient comfort compared to the transfemoral approach. However, challenges remain in optimizing hemostasis following TRA, particularly in balancing rapid vascular sealing with minimizing radial artery occlusion (RAO) and access-site complications. Prolonged compression protocols—commonly lasting 90 to 120 minutes in the United States—can lead to discomfort, delayed discharge, and increased healthcare burden. Therefore, there is a pressing need for novel strategies that accelerate hemostasis without compromising vessel integrity.
This first-in-human pilot study evaluated a new topical hemostatic agent: hydrophobically modified polysaccharide-chitosan (hm-P), combined with minimal pneumatic compression using the TR Band (TRB). The hm-P patch was designed to enhance tissue adhesion and promote rapid formation of a stable hemostatic plug through cross-linking of red blood cells within the wound site, leveraging the inherent biocompatibility and hemostatic properties of chitosan while improving consistency and performance via hydrophobic modification. The primary endpoint was time to hemostasis (TTH), defined as the interval from sheath removal to complete deflation of the TRB with confirmed surface hemostasis.
Fifty adult patients undergoing elective 6 Fr diagnostic coronary or peripheral angiography via TRA were enrolled at a single academic center. All participants underwent pre-procedural assessment including physical examination and Barbeau plethysmography to confirm dual arterial supply to the hand. Procedural anticoagulation consisted of unfractionated heparin (50 U/kg, max 5,000 U), along with verapamil or nitroglycerin to prevent spasm. At the end of the procedure, the sheath was withdrawn 2–3 cm, an hm-P patch was applied over the puncture site, and the TRB was inflated to 15 ml of air. A rapid deflation protocol was initiated: the band was quickly deflated until a flash of blood appeared under the patch or reached 5 ml, then reinflated by 2–3 ml until oozing stopped. Ipsilateral ulnar compression was maintained, and patent hemostasis was confirmed via plethysmography.
The median TTH was 40.5 minutes (IQR: 38–50 min), representing a substantial reduction compared to the conventional 90–120-minute standard. Notably, 78% of patients (n = 39) required no reinflation of the TRB, achieving hemostasis in just 39.0 minutes (IQR: 38–42 min). Among those requiring one or more reinflation cycles (n = 11), the median TTH was 54 minutes (IQR: 52–61 min). No patient experienced late bleeding or clinically significant complications during follow-up. Vascular ultrasound performed immediately before discharge confirmed patency of the radial artery at both proximal and distal sites in all patients, with no evidence of dissection, wall thickening, or thrombosis—resulting in a 0% RAO rate.Msi1 Antibody manufacturer
One mild superficial hematoma (EASY Grade I) occurred but resolved without intervention.Tenascin Antibody In Vitro There were no reports of cutaneous reactions, pseudoaneurysms, or persistent access-site bleeding.PMID:34990451 Patients with higher BMI had lower risk of early bleeding, whereas those with low body weight, liver dysfunction, or absence of hypertension were more likely to require TRB reinflation.
These findings demonstrate that the hm-P patch, when used with minimal pneumatic compression, enables safe and predictable hemostasis after TRA. The short TTH reduces post-procedural monitoring needs, facilitates earlier discharge, and enhances workflow efficiency in catheterization laboratories. Furthermore, the preservation of radial artery patency suggests a significant advantage over traditional methods that rely on prolonged compression, which are associated with higher RAO rates.
In summary, this pilot study provides robust preliminary evidence that topical hm-P application significantly accelerates hemostasis without increasing complication risks. With further validation in larger multicenter trials, this innovative approach could redefine standards for post-TRA care, offering a reliable, efficient, and patient-friendly solution for vascular access management in modern interventional cardiology.MedChemExpress (MCE) offers a wide range of high-quality research chemicals and biochemicals (novel life-science reagents, reference compounds and natural compounds) for scientific use. We have professionally experienced and friendly staff to meet your needs. We are a competent and trustworthy partner for your research and scientific projects.Related websites: https://www.medchemexpress.com
