pGlcNAc Fibers Demonstrate Effectiveness in a Variety of Clinical Trials and Applications

SyvekExcel^® safely controlled bleeding at arterial access sites and early ambulation, even with nearly immediate sheath removal and systematic anticoagulation using bivalirudin.

Femoral artery hemostasis and 2-hr ambulation after interventional cardiac catheterization were consistently achieved with the SyvekExcel topical, vascular-access, hemostasis system in anticoagulated patients.

Different glucosamine polymers can have very different abilities to activate hemostatic systems. Microalgal-derived pGlcNAc was found to be the most effective polymeric material for accelerating fibrin polymerization.

A catalytic surface for thrombin generation and accelerated fibrin clot formation results from the interaction of platelets with pGlcNAc.

Poly-N-acetyl glucosamine fiber material affects the clotting of blood by activation of platelets.

After 1 hour of supine bedrest, none of the 200 patients experienced a major adverse event with ambulation.

Poly-N-acetyl glucosamine fiber is capable of activating platelets by specific receptor-based interactions leading to rapid expression of vasoconstrictor substances and also resulting in the surface exposure of phosphatidylserine.

Poly-N-acetyl glucosamine fiber material promotes hemostasis by the activation of platelets.

The time to effective control of bleeding at the femoral insertion site was decreased in the pGlcNAc group by 37% versus patients receiving the placebo group.

Poly-N-acetyl glucosamine (pGlcNAc) helps to control bleeding through mechanisms that involve vasoconstriction, red blood cell agglutination and platelet activation for fibrin clot formation.

The mechanism of action of the pGlcNAc polymer activates several aspects of the physiological and biochemical cascades, resulting in control of bleeding.

Syvek leads to rapid cessation of bleeding without leaving foreign material at the arterial puncture site or in the tissue tract, thereby reducing the potential for infection and for localized inflammatory tissue responses.

Fully acetylated pGlcNAc reduced mortality, total blood loss, and total intravenous fluid requirements, and increased survival time when used as an adjunct to standard abdominal packing after severe liver injury.

The use of the SyvekPatch® on a total of 1,000 consecutive patients resulted in the rapid control of bleeding.

The Miami Heart cath lab completed a study using Angiomax® (bivalirudin) and the SyvekPatch®, testing early sheath removal. Results were excellent, and this protocol has become standard for some clinicians in the cath lab.

pGlcNAc produced a concentration-dependent vasoconstriction via an endothelium-dependent mechanism, partly via enhancement of endothelin-1 release from endothelial cells.

The p-GlcNAc membrane required fewer cycles of compression in the swine splenic incision model to control bleeding than either absorbable collagen or oxidized cellulose.

Extensive compression following dialysis can result in costly operational inefficiencies, expose patients and staff to bloodborne pathogens, and contribute to vascular access damage. Syvek was found to be a safe and effective method to rapidly control bleeding in hemodialysis patients versus manual compression with gauze or using clamps (n = 50). There were no cases of re-bleeding when using Syvek, and it significantly reduced compression time for hypertensive patients and patients taking concomitant anticoagulation.

The mrdh bandage stops both venous and arterial bleeding, even in the presence of a coagulopathy.

A prospective study of trauma patients suffering serious hemorrhage at 10 Level 1 trauma centers in the United States and at one U.S. Combat Support Hospital in Iraq.

In an ascending aorta graft, being performed on a patient with acute type A dissection, attempts at suturing and other maneuvers failed to control hemorrhage. Modified rapid deployment hemostat (MRDH) was successful in controlling hemorrhage. It is a novel hemostatic agent with invaluable use in troublesome bleeding occurring during heart surgery.

Comparison of the properties of the poly-N-acetyl glucosamine fiber-derived materials with chitin, chitosan, and commercial chitosan-based products are presented. The results demonstrate that hemostatic responses to the glucosamine-based materials studied are highly dependent on their chemical nature and tertiary/quaternary structure. The unique natural microalgal fibers were found to have strongly prohemostatic activity compared to the other materials studied.

A catalytic surface for thrombin generation and accelerated fibrin clot formation results from the interaction of platelets with pGlcNAc.

More than 80% of all early civilian trauma deaths are due to uncontrolled hemorrhage, and half of these are from severe liver injuries.1 Blunt high-grade hepatic injuries requiring operative intervention have a mortality rate from 50 to 100%.2–4 Several hemostatic devices and dressings are being developed to aid in controlling bleeding from these deadly injuries.5

Hemostasis can be difficult to achieve after blunt abdominal trauma, particularly if the patient is coagulopathic. The U.S. Food and Drug Administration has recently approved the Rapid Deployment Hemostat (RDH) bandage (Marine Polymer Technologies, Cambridge, MA) as a treatment for external bleeding after extremity trauma.

Eighty percent of the animals treated with the RDH Bandage survived the study through the entire protocol, whereas only 40% of those treated with the Army First Aid Field Bandage survived the removal of manual compression step.