Hemostatic efficacy of a novel, PEG-coated collagen pad in clinically relevant animal models

Lewis, Kevin M.; Schiviz, Alexandra; Hedrich, Hans-Christian; Regenbogen, Johannes; Goppelt, Andreas

doi:10.1016/j.ijsu.2014.07.017

Cited by 24 publications

(22 citation statements)

References 34 publications

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“…PCC was previously evaluated in several clinically relevant preclinical hepatic and vascular bleeding models with mild to moderate bleeding showing superior performance when compared to FTC and oxidized cellulose [21,22]. Consistent with a preclinical report investigating FTC in a heparinized swine spleen incision model, a high adhesive failure rate was observed in the present study as was evident in the histology images and by hematoma formation in 76% of lesions treated with FTC compared to no observed hematoma in the PCC antiplatelet group.…”

Section: Discussionsupporting

confidence: 85%

Treatment of Severe Aortic Bleeding Using Hemopatch in Swine on Dual Antiplatelet Therapy

Baumgartner

Draxler

Lewis

2016

Journal of Investigative Surgery

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Purpose: The perioperative management of patients on antithrombotic therapy is currently an unresolved problem as these therapies pose a considerable risk for perioperative hemorrhagic complications. The presented studies investigated the efficacy of a new collagen technology to achieve hemostasis. A polyethylene glycol-coated collagen pad (PCC) was compared to a marketed fibrinogen-thrombin coated collagen pad (FTC) for the treatment of an aortotomy incision in heparinized swine on dual antiplatelet therapy. Materials and Methods: Twenty-eight 3-mm aortotomy incisions were created in nine heparinized pigs without antiplatelet therapy and treated with PCC. Sixty-eight aortotomy incisions were created in ten heparinized pigs that received clopidogrel (10-11 mg/kg) and acetylsalicylic acid (8-11 mg/kg) orally for 5 days, and treated with either PCC or FTC (N = 34/group). Dual antiplatelet therapy resulted in significantly reduced platelet function. Aortotomy incisions resulted in lifethreatening bleeding of 35-292 ml/min. Results: In animals without antiplatelet treatment, PCC provided 96% immediate hemostatic success. In animals with antiplatelet treatment, FTC provided 18% immediate hemostatic success increasing to 74% after 10 min. Strikingly, PCC provided 94% immediate success increasing to 100% after 10 min. Controlling for differences in pretreatment bleeding rates, statistical model-estimated time to hemostasis was 12 times shorter in PCC-treated lesions (p < .02). Conclusion: The combination of a procoagulant collagen pad with a synthetic sealing component provides excellent hemostatic properties under a worst-case scenario. PCC rapidly and firmly adheres to tissue, thereby controlling severe arterial bleeding, even when platelet function is significantly reduced. Treatment with PCC provided superior time to hemostasis compared to FTC.

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Section: Discussionsupporting

confidence: 85%

Treatment of Severe Aortic Bleeding Using Hemopatch in Swine on Dual Antiplatelet Therapy

Baumgartner

Draxler

Lewis

2016

Journal of Investigative Surgery

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“…Hemopatch is a new hemostatic pad with a dual mechanism of action: a sealing effect and the induction of clot formation [1]. It consists of a bovine-derived collagen pad, marked on one side with blue squares for easy visualization (nonactive side) [2].…”

Section: Commentmentioning

confidence: 99%

“…On contact with blood and fluids, the PEG-based sealant forms covalent bonds with blood proteins and the underlying tissue, thus fixing the pad to the application site and sealing the wound [2]. Subsequently, blood penetrates the collagen pad, where platelets become entrapped in the collagen fibers, with the resulting formation of a fibrin clot [1]. This leads to reliable hemostasis and sealing of tissues.…”

Section: Commentmentioning

confidence: 99%

Hemopatch Application for Ventricular Wall Laceration in Redo Cardiac Surgical Procedures

Sandrio

Purbojo

Cesnjevar

et al. 2016

The Annals of Thoracic Surgery

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“…A polyethylene glycol-coated, collagen-based, sealing hemostatic patch (Hemopatch Ò , Baxter Healthcare Ltd.) has been designed to stop bleeding during surgical procedures and to simultaneously induce hemostasis [1,2]. This collagen-based hemostatic patch was safe and performed well against other sealing hemostats when tested in vivo using various surgical models [3][4][5][6][7][8][9], and in a range of surgeries in patients [10][11][12][13][14][15][16][17]. This case report is the first to describe the use of the collagen-based hemostatic patch for repair of vascular injury in a neurosurgical case involving the removal of meningioma in the foramen magnum.…”

Section: Introductionmentioning

confidence: 99%

Case Report of a Novel Technique for Repair of the Vertebral Artery During Cranial Surgery

Prasad¹,

Mukerji²

2019

Neurol Ther

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Surgery of complex cranial base lesions carries a high risk of damage to main vessels, often resulting in life-changing or even life-threatening injuries. We describe a rapid, effective, and noninvasive application of a collagen-based hemostatic patch to repair the vertebral artery during cranial surgery. A 61-year-old male patient underwent retrosigmoid craniotomy to remove a foramen magnum meningioma that encased the vertebral artery. A linear incision was made behind the ear and standard retrosigmoid craniotomy was performed with preservation of the transverse and sigmoid sinuses. The dura was opened in a Y-shaped fashion and the cerebellum was retracted with cerebrospinal fluid being released. Removing the exposed tumor from the artery resulted in a small arterial bleed. Two pieces of an N-hydroxysuccinimide-functionalized polyethylene glycol-coated collagen patch (Hemopatch Ò , Baxter Healthcare Ltd.) were applied sequentially and were pressed to the bleed site for 2 min each. Hemostasis of the vertebral artery was achieved at the patient's regular blood pressure. There was no postoperative bleeding, dissection or pseudoaneurysm. The patient recovered gradually with several cranial nerve deficits. There was no brain stem stroke. Twelve months on, the patient has made an excellent recovery from surgery, is independently mobile and has minimal cranial nerve deficits. Application of the collagen-based hemostatic patch proved to be an efficient, safe, and noninvasive technique that achieved rapid hemostasis, confirming its effectiveness in complicated surgery, where risk of hemorrhage can be critical for the surgery outcome.

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Hemostatic efficacy of a novel, PEG-coated collagen pad in clinically relevant animal models

Abstract: PCC provided faster hemostasis than ORC in a vascular and hepatic surgical model with impaired coagulation.

Cited by 24 publications

References 34 publications

Treatment of Severe Aortic Bleeding Using Hemopatch in Swine on Dual Antiplatelet Therapy

Treatment of Severe Aortic Bleeding Using Hemopatch in Swine on Dual Antiplatelet Therapy

Hemopatch Application for Ventricular Wall Laceration in Redo Cardiac Surgical Procedures

Case Report of a Novel Technique for Repair of the Vertebral Artery During Cranial Surgery

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