Hemostatic Agents in Hepatobiliary and Pancreas Surgery: A Review of the Literature and Critical Evaluation of a Novel Carrier-Bound Fibrin Sealant (TachoSil)

Table 1

Topical hemostatics and sealant agents approved by the FDA as of December 2011.

Product	Approval year	Manufacturer	Description	Indication
OMNEX	2010	Ethicon, Inc. a Johnson and Johnson Company, Somerville, NJ	Two cyanoacrylate monomers	For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
TachoSil	2010	Nycomed GmbH, Linz, Austria	A ready-to-use surgical patch composed of a dry collagen sponge made from horse tendons, and on one side coated with human fibrinogen and thrombin	An adjunct to hemostasis in cardiovascular surgery when control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.
Recothrom	2008	Zymogenetics, Seattle, WA	Recombinant thrombin	Aid in hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.
Evicel	2007; (Changed from Crosseal which was approved in 2003 when indication expanded to include use during vascular surgery)	Johnson and Johnson, Somerville, NJ; OMRIX biopharmaceuticals Ltd. Kiryat Ono, Israel	Fibrin sealant—human pooled	An adjunct to hemostasis for use in patients undergoing surgery (liver and vascular surgery are also separately indicated) when control of bleeding by conventional surgical techniques is ineffective or impractical.
Evithrom	2007	Johnson and Johnson, Somerville, NJ	Lyophilized human pooled thrombin	Aid in hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.
Thrombin-JMI	2007	King Pharmaceuticals, Bristol, TN	Bovine thrombin	Aid in hemostasis whenever oozing blood or minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.
CryoSeal Fibrin Sealant System	2007	Thermogenesis, Rancho Cordova, CA	Fibrin sealant-human	An adjunct to hemostasis on the incised liver surface in patients undergoing liver resection when control of bleeding by standard surgical techniques is ineffective or impractical.
Arista AH	2006	Medafor, Minneapolis, MN	Polysaccharide spheres	For use in surgical procedures (except neurological and ophthalmological) as an adjunctive hemostatic device to assist when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
Vitagel	2006	Orthovita, Malvern, PA	Fibrin sealant-individual units of plasma, bovine collagen, and bovine thrombin	For use during surgical procedures (except neurosurgery and opthalmic surgery) as an adjunct to hemostasis when control of bleeding by ligature or other conventional procedures is impractical or ineffective.
CoStasis	2000	Cohesion Technologies Inc., Palo Alto, CA	Flowable bovine collagen and licensed bovine thrombin	In surgical procedures (other than neurological, opthalmological, and urological) as an adjunct to hemostasis, when control of bleeding by ligature or conventional procedures are ineffective or impractical.
TISSEEL	1998, new formulation in 2006	Baxter Healthcare Corporation, Westlake Village, CA	Fibrin sealant-human pooled	An adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries. TISSEEL is satisfactory for use in fully heparinized patients undergoing cardiopulmonary bypass. Also, indicated as an adjunct to prevent leakage from colonic anastomosis following the reversal of temporary colostomies.
Hemostase MPH	2006	Cryolife, Kennesaw, GA	Absorbable powder hemostatic	In surgical procedures (except neurological and opthalmological) as an adjunct hemostatic device when control of capillary, venous, and arteriolar bleeding by conventional means proves ineffective or impractical.
Surgiflo	2005	Johnson and Johnson, Somerville, NJ	Porcine gelatin with or; without thrombin	In surgical procedures (except opthalmological) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
Duraseal	2005	Covidien, Waltham, MA	Single polyethylene glycol	An adjunct to sutured dural repair during cranial surgery to provide watertight closure. In 2011, additional approval for spine.
CoSeal	2003	Baxter Healthcare Corporation, Hayward, CA	Two polyethylene glycols	For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Bioglue	2001	Cryolife, Kennesaw, GA	Bovine albumin and 10% glutaraldehyde	Adjunct to standard methods of achieving hemostasis (such as sutures or staples) in adult patients in open surgical repair of large blood vessels such as aorta or the femoral and carotid arteries.
Avitene Ultrafoam sponge and flour	2001	Bard, Murray Hill, NJ	Collagen-based absorbable hemostatic	For all surgical procedures including neurosurgery and urology as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
FloSeal Hemostatic Matrix	1999	Baxter Healthcare Corporation, Hayward, CA	Flowable bovine gelatin matrix and licensed human thrombin	In surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Surgifoam sponge and powder	1999	Johnson and Johnson, Somerville, NJ	Porcine gelatin sponge	In surgical procedures (other than neurological, urological, and opthalmological surgery) as an adjunct to hemostasis when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
Hemopad Novacol	1986	Datascope Corp., Montvale, NJ	Bovine collagen	As a hemostatic device, when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is either ineffective or impractical.
Helistat Helitene	1985	Integra Life Science, Plainsboro, NJ	Bovine collagen	In surgical procedures (other than opthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by standard surgical procedure is impractical.
Instat, Instat MCH	1985	Johnson and Johnson, Somerville, NJ	Purified and lyophilized bovine dermal collagen	In surgical procedures (other than urological and ophthalmological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Gelfoam sponge and powder	1983	Pharmacia, Kalamazoo, MI	Porcine gelatin molded into a sponge	An aid in hemostasis, when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is either ineffective or impractical.
CollaStat	1981	Integra Life Sciences Corporation, Plainsboro, NJ	Absorable bovine collagen sponge	In surgical procedures (other than opthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by standard surgical procedure is impractical.
Surgicel, SurgiCel Fibrillar, and Nu-Knit	1960	Johnson and Johnson, Somerville, NJ	Sponge of oxidized cellulose	Adjunct in surgical procedures to assist in control of capillary, venous, and small arterial hemorrhage when standard surgical techniques are ineffective or impractical.