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

Report
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
Hemostatic Agents in the OR: Are You Providing
Safe Care?
 Haemostatic Agent Characteristics
CATEGOR
Y
SAFETY
EFFICACY
EASE OF USE
COST
Mechanical
Relatively Safe
Swelling
Minimal Bleeding
Easy to
prepare/use
Inexpensive
Active
Potential for:
Antibody Formation,
Disease Transmission:
Viral, Prion
Recombinant
Effective for
localized & diffuse
bleeding
Relatively easy to
prepare/use
Moderately priced
Flowable
Disease Transmission:
Viral, Prion
Localized Bleeding
Relatively easy to
prepare/use
More expensive
than active
Fibrin Sealant
Disease Transmission:
Viral, Prion
Antibody
formation/swelling
Coagulation profile
important to know
Localized and
Diffuse Bleeding
More difficult to
prepare/use
Most expensive
Hemostatic Agents in the OR: Are You Providing
Safe Care?
 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
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
Polysaccharide
Spheres
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
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
Pooled Human
Thrombin
Swelling risk; Do not use in patients with
allergies to Human blood products;
unknown potential for infection
transmission and interruption of clotting
cascade
Evithrom
Commercially manufactured; to date
clinical studies have not demonstrated
this product has produced antigens or
impacted clotting cascade
Recothrom
Recombinant Thrombin
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 68 weeks; not to be used with blood
Salvage devices or Cardio-pulmonary
Bypass circuits; potential for infection
transmission
Floseal
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
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 PlasmaDerived Fibrin
Sealant
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 CPBypass 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.
Tisseal
Evicel
Crosseal
Patient ‘s Own
Plasma with
Bovine
Collagen/Throm
bin
Patient ‘s Own
Plasma to create
Fibrinogen and
thrombin
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 antiflammatory agent use (48 hrs); adjunct for liver
resection surgery; studies indicate clot
stability and Fibrinogen less effective than
commercially prepared products
Vitagel
Cryoseal
Hemostatic Agents in the OR: Are You Providing Safe Care?
Current Products –Peg Polymers ,Cyanoacrylates,
Glutaraldehydes
CATEGORY
ACTION
COMPOSITION
/ORIGIN
CLINICAL CONSIDERATIONS
COMMERCIAL NAME
Peg Polymers
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
Coseal
Cyanoacrylates
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
Used as a replacement for sutures
primarily on facial, extremity and
torso wounds; attains strength of
healed tissue after 7 days
Dermabond
Indermil
Glutaraldehyde
cross linked
with bovine
albumin
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
Glutaraldehydes
Hemostatic Agents in the OR: Are You
Providing Safe Care?
 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
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
CLASS
Bovine Collagen
Oxidized Regenerated Cellulose
Polysaccharide Spheres
Gelfoam/Surgifoam Powder and
Sponge
Avitene, Helistat, Instat, Ultrafoam
Surgical, Surgicel Fibrillar, Nu-Knit
Arista, Hemostase, Vitasure
ACTIVE
Bovine Thrombin
Pooled Human Thrombin
Recombinant Thrombin
Thrombin – JMI
Evithrom
FDA Approved Hemostats
Recothrom
FLOWABLE
Bovine Gelatin & Pooled Human
Thrombin
Porcine Gelatin (+/- Thrombin)
Floseal.
Pooled human Plasma
Individual Human Plasma W
Bovine Collagen & Bovine
Thrombin
Individual Human Plasma
Tisseal, Evicel
Vitagel
FIBRIN SEALANT
Porcine Gelatin
PRODUCT
FDA
Surgiflo
Cryoseal
Hemostatic Agents in the OR: Are You
Providing Safe Care?
 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?
 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?
 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.

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