Effectiveness of a new carrier-bound fibrin sealant versus argon beamer as haemostatic agent during liver resection: a randomised prospective trial.
OBJECTIVE
A new carrier-bound fibrin sealant, TachoSil, is expected to be efficacious and safe as a haemostatic treatment in hepatic resection.


METHODS
A prospective, randomised, open and controlled multicentre trial with intraoperative as well as postoperative assessment of efficacy and a 1 month follow-up period.


METHODS
Tertiary care centres.


METHODS
One hundred and twenty-one patients requiring secondary haemostasis during planned liver resection. Patients with coagulation disorders and patients with persistent major bleeding after primary haemostatic measures were excluded.


METHODS
Application of either carrier-bound fibrin sealant (n=59) or argon beamer (argon beam coagulator) (n=62) as secondary haemostatic treatment.


METHODS
Time to intraoperative haemostasis.


RESULTS
There was a significant superiority of TachoSil over argon beamer with regard to time to haemostasis (3.9 min, median 3.0, range 3-20 min vs 6.3 min, median 4.0, range 3-39 min) (P=0.0007). Haemoglobin concentration of drainage fluid was significantly lower on day 2 after surgery in TachoSil patients (1.1 mmol/l) than in argon beamer patients (2.3 mmol/l) (P=0.012). Overall, the frequency and causality of adverse events did not differ between the two treatment groups.


CONCLUSIONS
TachoSil is superior to argon beamer in obtaining effective and fast intraoperative haemostasis. The safety data show TachoSil to be tolerable and safe for haemostatic treatment in liver resection.
Frilling
Andrea
A
Department of General Surgery and Transplantation, University Hospital of Essen, Hufelandstrasse 55, 45147 Essen, Germany. frilling@uni-essen.de
Stavrou
Gregor A
GA
Mischinger
Hans-Jörg
HJ
de Hemptinne
Bernard
B
Rokkjaer
Mogens
M
Klempnauer
Jürgen
J
Thörne
Anders
A
Gloor
Beat
B
Beckebaum
Susanne
S
Ghaffar
Mohamed F A
MF
Broelsch
Christoph E
CE
D004337:Drug Carriers; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006488:Hemostasis, Surgical; D006490:Hemostatics / Q000627:therapeutic use*; D006498:Hepatectomy; D006801:Humans; D017075:Laser Coagulation; D011446:Prospective Studies; D016896:Treatment Outcome
D004337:Drug Carriers; D015718:Fibrin Tissue Adhesive; D006490:Hemostatics
Surg Today. 2002;32(1):48-52
11871817
Br J Surg. 2000 Jun;87(6):790-5
10848861
Br J Surg. 1993 Dec;80(12):1563-5
8298927
Int Surg. 1996 Jul-Sep;81(3):316-9
9028999
Br J Surg. 1996 Nov;83(11):1526-9
9014666
Arch Surg. 2003 Nov;138(11):1198-206; discussion 1206
14609867
Am J Surg. 1995 Jun;169(6):589-94
7771622
Hepatogastroenterology. 1996 Jan-Feb;43(7):221-4
8682467
Dig Liver Dis. 2001 May;33(4):341-6
11432513
Arch Surg. 2000 Oct;135(10):1200-4; discussion 1205
11030881
J Am Coll Surg. 2000 Jul;191(1):38-46
10898182
Ann Surg. 1991 Dec;214(6):689-95
1741648
Arch Surg. 2004 Nov;139(11):1148-54
15545559
Surgery. 1992 Jul;112(1):32-6
1320298
World J Surg. 1998 Apr;22(4):406-12
9523524
Hepatogastroenterology. 1998 Jan-Feb;45(19):184-90
9496510
Thorac Cardiovasc Surg. 1994 Oct;42(5):306-9
7863495
Ann Surg. 2003 Jun;237(6):871-6; discussion 876
12796584
World J Surg. 1992 Sep-Oct;16(5):966-9; discussion 970
1462639
J Am Coll Surg. 1996 Sep;183(3):230-8
8784316
Ann Surg. 1993 Dec;218(6):748-53
8257225