Hemostatic Agents in the OR: Are You Providing Safe Care?

Peggy Camp, RN, BSN, MSN September 13, 2012

Hemostatic Agents in the OR: Are You Providing Safe Care?

 Today’s presentation will provide a review and update on:  The types and properties of topical haemostatic sealants commonly used in the Peri-operative setting.   Common surgical applications FDA approved Products/applications    Clinical Facts for the Peri-operative Nurse Potential Complications “Take-aways” for Clinicians

Hemostatic Agents in the OR: Are You Providing Safe Care?

Historical Overview

Major Factors affecting today’s surgical environment

 Cost Containment  Growing Aging Population

Impact on today’s care delivery systems

 Growth in less invasive procedures  Emergence of new products to control bleeding, enhance clinical outcomes

Hemostatic Agents in the OR: Are You Providing Safe Care?

What has changed in the past 5 years in health care delivery?

 Emphasis on controlling costs  Increase in minimally invasive procedures in the OR and other clinical areas (IR, Cath Lab)  Expectation of improved clinical outcomes  High level of oversight on clinical interventions and outcomes     Surgical Complications including SSI, readmissions Blood Transfusions Implants Advanced Haemostatic Agents

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Hemostatic Agents in the OR: Are You Providing Safe Care?

Haemostatic Agent Characteristics CATEGOR Y Mechanical Active Flowable Fibrin Sealant SAFETY EFFICACY EASE OF USE COST Relatively Safe Swelling Potential for: Antibody Formation, Disease Transmission: Viral, Prion Recombinant Minimal Bleeding Effective for localized & diffuse bleeding Easy to prepare/use Relatively easy to prepare/use Disease Transmission: Viral, Prion Disease Transmission: Viral, Prion Antibody formation/swelling Coagulation profile important to know Localized Bleeding Localized and Diffuse Bleeding Relatively easy to prepare/use More difficult to prepare/use Inexpensive Moderately priced More expensive than active Most expensive

Hemostatic Agents in the OR: Are You Providing Safe Care?

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Current products -MECHANICAL CATEGORY ACTION COMPOSITION/ORIGIN CLINICAL CONSIDERATIONS COMMERCIAL NAME Mechanical

Minimal Bleeding

Porcine Gelatin

Swelling (do not use in confined areas); do not use in infected cases; may cause foreign body reaction if not removed Gelfoam Powder /Sponge Surgifoam Powder /Sponge

Bovine Collagen Polysaccharide Spheres

Swelling (do not use in confined areas); do not use in infected cases; may cause foreign body reaction if not removed; adhesion formation Avitene sponge & flour; Helistat and Helitene; Instat

Oxidized Regenerated Cellulose

Swelling (do not use in confined areas); do not use in infected cases; may cause foreign body reaction if not removed; adhesion formation Surgicel, Surgicel Fibrillar, and Nu-Knit Swelling (do not use in confined areas); no demonstrated safety studies in neurologic, urologic and ophthalmic surgery; should not be injected Arista

Hemostatic Agents in the OR: Are You Providing Safe Care?

Current products -ACTIVES

CATEGORY ACTION COMPOSITION/ORIGIN CLINICAL CONSIDERATIONS COMMERCIAL NAME Actives

Localized and Diffuse Bleeding

Bovine Thrombin Pooled Human Thrombin Recombinant Thrombin

Should not be used for patients with bovine allergies; can stimulate Antigen formation and interrupt clotting cascade ; potential for infection transmission; has Black Box Warning Thrombin Evithrom Swelling risk; Do not use in patients with allergies to Human blood products; unknown potential for infection transmission and interruption of clotting cascade Commercially manufactured; to date clinical studies have not demonstrated this product has produced antigens or impacted clotting cascade Recothrom

Hemostatic Agents in the OR: Are You Providing Safe Care?

Current Products -FLOWABLES

CATEGORY ACTION COMPOSITION/ORIGIN CLINICAL CONSIDERATIONS COMMERCIAL NAME Flowables

Localized bleeding Bovine Gelatin and Human Thrombin Should not be used for patients with bovine allergies; swelling risk – approved for use in all specialties EXCEPT Ophthalmology; absorption 6 8 weeks; not to be used with blood Salvage devices or Cardio-pulmonary Bypass circuits; potential for infection transmission Porcine Gelatin with/without Thrombin Swelling risk; absorption in 4-6 weeks. Do not use in patients with Porcine allergies; not to be used with blood Salvage devices or Cardio-pulmonary Bypass circuits; potential for infection transmission * Can be used in combination with Recothrom Floseal Surgiflo

Hemostatic Agents in the OR: Are You Providing Safe Care?

Current Products –Fibrin Sealants CATEGORY ACTION COMPOSITION/ ORIGIN CLINICAL CONSIDERATIONS COMMERCIAL NAME Fibrin Sealants

Localized and Diffuse Bleeding Human Plasma Derived Fibrin Sealant Patient ‘s Own Plasma with Bovine Collagen/Throm bin Patient ‘s Own Plasma to create Fibrinogen and thrombin 2 component hemostat & sealant –contains pooled human plasma fibrinogen and & thrombin – doesn’t need active bleeding or blood –derived fibrinogen for activation - do not to use with Blood Salvage devices or CP Bypass circuits; potential concerns infection transmission, air embolus, tissue rupture and gas entrapment.

Systems differ in terms of storage and application. Potential concerns –do not use in patients with Bovine allergies, infection/ foreign body reaction/swelling/tissue compression ; immunologic and coagulation complications.

Requires trained technician for processing; not be used in patients with acquired or hereditary hematologic or coagulation disorders; not be used with patients on active heparin or Coumadin therapy or non-steroidal anti flammatory agent use (48 hrs); adjunct for liver resection surgery; studies indicate clot stability and Fibrinogen less effective than commercially prepared products Tisseal Evicel Crosseal Vitagel Cryoseal

Hemostatic Agents in the OR: Are You Providing Safe Care?

CATEGORY Peg Polymers Current Products –Peg Polymers ,Cyanoacrylates, Glutaraldehydes ACTION COMPOSITION /ORIGIN CLINICAL CONSIDERATIONS

Two synthetic polymers that mix and cross link at the wound site Polyethylene glycol hydrogels Can prevent pericardial adhesions; good agent for vascular reconstructions; does not cause inflammation; infection risks minimal; should not be used in closed spaces because of swelling risk

Cyanoacrylates COMMERCIAL NAME

Coseal Dermabond Indermil

Glutaraldehydes

Monomers form polymers in presence of water and serves to glue surfaces together Achieves 65% binding power in 20 sec; full strength in 2 min regardless of temperature /air /water Liquid monomers Glutaraldehyde cross linked with bovine albumin Used as a replacement for sutures primarily on facial, extremity and torso wounds; attains strength of healed tissue after 7 days Commonly used in vascular procedures for sealing holes around staple lines; good agent for arterial bleeds; hyper-sensitivity a concern; inert substance that is NEVER absorbed Bioglue

Hemostatic Agents in the OR: Are You Providing Safe Care?

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Common Surgical Applications*

General Surgery - Hernia Mesh Fixation, Fundoplication, Bariatric Surgery, Colostomy Closure, Burns Cardiac Surgery - Effective agent for active bleeding sites ; some agents help to prevent adhesions Head & Neck Surgery – thyroidectomies, septoplasties - good agent for controlling active bleeding Neurosurgery - Control active bleeding in intra-cerebral hemorrhage, effective in sealing CSF Leakage Orthopedic Surgery - Limited applications include Achilles Tendon Repairs; should not be used with methylmethacrylates

OB-GYN Surgery - Laparoscopic Ovarian Cystectomies, Abdominal Myomectomy,

Laparoscopic Ovarian Cystectomies

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Hemostatic Agents in the OR: Are You Providing Safe Care?

Common Surgical Applications

Ophthalmologic Surgery – Eyelid procedures to seal suture lines/tissues; limited applications for treatment of corneal perforations or glaucoma bleb leaks Thoracic Surgery – seal air leaks in Lung Resections Urologic Surgery - Laparoscopic Nephrectomy Vascular Surgery – Broad applications for active bleeding – Aortic Aneurysms, Peripheral Vascular Procedures, i.e. Carotid Endarterectomy, Av Access Procedures *Note – there are a number of outcome studies in all specialties that indicate less intra/post bleeding and new applications are emerging on a daily basis.

Haemostatic Agents in the OR: Are You Providing Safe Care?

FDA Approved Products

CATEGORY

MECHANICAL Porcine Gelatin

CLASS

Bovine Collagen Oxidized Regenerated Cellulose Polysaccharide Spheres ACTIVE FLOWABLE Bovine Thrombin Pooled Human Thrombin Recombinant Thrombin Bovine Gelatin & Pooled Human Thrombin Porcine Gelatin (+/- Thrombin) FIBRIN SEALANT Pooled human Plasma Individual Human Plasma W Bovine Collagen & Bovine Thrombin Individual Human Plasma Floseal.

Surgiflo Tisseal, Evicel Vitagel Cryoseal

PRODUCT

Gelfoam/Surgifoam Powder and Sponge Avitene, Helistat, Instat, Ultrafoam Surgical, Surgicel Fibrillar, Nu-Knit FDA Thrombin – JMI FDA Approved Hemostats Recothrom

Hemostatic Agents in the OR: Are You Providing Safe Care?

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FACTS TO CONSIDER

 What is the origin of the product being used & what are the patient implications?

 What clinical studies are there to support the application being considered  How easy is the product to use?

 What benefits are there for this product?

 What limitations are there for this product?

 What does the product cost & does clinical outcomes justify this expense?

 What safety mechanisms are in place to insure optimal patient outcomes ---what needs to be considered?

Hemostatic Agents in the OR: Are You Providing Safe Care?

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IMMUNE-MEDIATED COAGULOPATHY (IMC)

 Iatrogenic medical condition resulting from exposure to non-human coagulation proteins (porcine and bovine) thrombin  Has been noted in all surgical specialties (Trauma)  True incidence unknown due largely to under reporting (2000)  Delayed onset – most often following surgical procedures where Bovine Thrombin used  Increased Morbidity and Mortality  Difficult to Diagnose and Manage  Is an AVOIDABLE complication

Hemostatic Agents in the OR: Are You Providing Safe Care?

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IMMUNE-MEDIATED COAGULOPATHY (IMC)

 • • • • • Strategies to improve patient outcomes Patient Assessment Identification of high risk/at risk patients Education of Surgical Team (including Physicians) Using the right product for the right reason Timely intervention

Hemostatic Agents in the OR: Are You Providing Safe Care?

“Take-aways” for the Peri-operative Nurse

 Understand the Risks and Benefits and Cost of Haemostatic Agents  Read the labels on the packaging including Black Box Warnings  Assessment is key for ALL patients – never assume that there have been no previous exposures  Educate yourself, your peers and your surgeons – stay current on published studies  When in doubt, STOP and ask questions

Hemostatic Agents in the OR: Are You Providing Safe Care?

References

 Achneck, H., Bantayehu,S., Jamiolkowski, R., Alba, D., Shapiro, M., Lawson, J. A comprehensive Review of Topical Hemostatic Agents. Annals of Surgery. 2010; 251: 217-228.

 Ness,P., Creer,M., Rodgers,G., Naoum, J., Renkens,K., Voils, S., Alexander, W., (RETACC Panel). Building an immune-mediated coagulopathy consensus: early recognition and evaluation to enhance post-surgical patient safety. Patient Safety

in Surgery. 2009: 10.1186-/1754-9493-3-8.

 Rodgers, G. Immune-mediated Coagulopathy Associated With Bovine Thrombin: Review of the Pediatric Literature. Journal of Pediatric Hematology/Oncology. 33:

2 86-88

 Spahn, R & Rossaint, R . Coagulopathy and blood component transfusion in trauma. British Journal of Anesthesia.2005: 95(2). 130-139.  Spotnitz, W and Burks, S. State-of-the-Art Review: Hemostats, Sealants,and Adhesives II: Update as Well as How and When to Use the Components of the Surgical Toolbox. Clinical and Applied Thrombosis/Hemostasis. 2010:16:497 –

513.