Efficacy of a haemostatic matrix for the management of bleeding in patients undergoing liver resection: Results from 237 cases

Francesco Izzo, Raimondo Di Giacomo, Paolo Falco, Mauro Piccirillo, Rossana Iodice, Antonio Pio Orlando, Pasquale Aprea, Francesco Cremona, Massimiliano Di Marzo, Domenico Nicola Idà, Angelo A. Mastro, Steven A. Curley

Research output: Contribution to journalArticle

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Abstract

Background: The haemostatic matrix (FloSeal*) is a topical agent that provides effective haemostasis in a range of surgical applications. We evaluated this sealant for intraoperative haemostatic effectiveness in an observational series of patients undergoing surgery for the resection of primary and metastatic liver tumours. Methods: A haemostatic matrix was applied directly to areas of bleeding. The severity of bleeding before and after application was graded on a 5-point scale (0 = no bleeding, 1 = oozing, 2 = moderate blood flow, 3 = heavy blood flow, 4 = spurting blood). The time to complete haemostasis was also recorded. Results: 105 women (age 61 ± 9 years) and 132 men (age 61 ± 12 years) were included in this study. One hundred and seventeen patients (49.36%) had pre-operative coagulopathy resulting from co-existent cirrhosis (67 Child-Pugh Class A; 50 Child-Pugh Class B). Prior to administration of a haemostatic matrix, 93 bleeding sites (24.8%) had a bleeding severity score of 2,269 bleeding sites (71.7%) had a score of 3 and 13 bleeding sites (3.5%) had a score of 4. Following administration of the haemostatic matrix, bleeding stopped completely (score of 0) at 367 (97.9%) of the 375 sites and was reduced to a score of 1 at the remaining 8 sites (2.1%), of which only 2 were in patients with coagulopathy. The mean time to achieve haemostasis in the overall population was 2.9 ± 1 min; this was significantly increased in patients with coagulopathy versus non-coagulopathic patients (4 ± 1 vs. 2 ± 1 min, p <0.001). Conclusions: In this prospective, uncontrolled study of 237 consecutive patients undergoing major hepatic surgery to remove primary or metastatic tumours, application of a haemostatic matrix provided rapid and effective intraoperative control of mild to severe bleeding from the liver edge, even in patients with prolonged bleeding times resulting from cirrhosis. This preliminary evidence warrants a randomised, controlled clinical trial with a larger sample size.

Original languageEnglish
Pages (from-to)1011-1015
Number of pages5
JournalCurrent Medical Research and Opinion
Volume24
Issue number4
DOIs
Publication statusPublished - Apr 2008

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Hemostatics
Hemorrhage
Liver
Hemostasis
Fibrosis
Bleeding Time
Sample Size
Neoplasms
Randomized Controlled Trials
Prospective Studies

Keywords

  • Haemostatic matrix
  • Hepatic surgery
  • Post-operative haemostasis
  • Topical

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Efficacy of a haemostatic matrix for the management of bleeding in patients undergoing liver resection : Results from 237 cases. / Izzo, Francesco; Di Giacomo, Raimondo; Falco, Paolo; Piccirillo, Mauro; Iodice, Rossana; Orlando, Antonio Pio; Aprea, Pasquale; Cremona, Francesco; Di Marzo, Massimiliano; Idà, Domenico Nicola; Mastro, Angelo A.; Curley, Steven A.

In: Current Medical Research and Opinion, Vol. 24, No. 4, 04.2008, p. 1011-1015.

Research output: Contribution to journalArticle

Izzo, Francesco ; Di Giacomo, Raimondo ; Falco, Paolo ; Piccirillo, Mauro ; Iodice, Rossana ; Orlando, Antonio Pio ; Aprea, Pasquale ; Cremona, Francesco ; Di Marzo, Massimiliano ; Idà, Domenico Nicola ; Mastro, Angelo A. ; Curley, Steven A. / Efficacy of a haemostatic matrix for the management of bleeding in patients undergoing liver resection : Results from 237 cases. In: Current Medical Research and Opinion. 2008 ; Vol. 24, No. 4. pp. 1011-1015.
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abstract = "Background: The haemostatic matrix (FloSeal*) is a topical agent that provides effective haemostasis in a range of surgical applications. We evaluated this sealant for intraoperative haemostatic effectiveness in an observational series of patients undergoing surgery for the resection of primary and metastatic liver tumours. Methods: A haemostatic matrix was applied directly to areas of bleeding. The severity of bleeding before and after application was graded on a 5-point scale (0 = no bleeding, 1 = oozing, 2 = moderate blood flow, 3 = heavy blood flow, 4 = spurting blood). The time to complete haemostasis was also recorded. Results: 105 women (age 61 ± 9 years) and 132 men (age 61 ± 12 years) were included in this study. One hundred and seventeen patients (49.36{\%}) had pre-operative coagulopathy resulting from co-existent cirrhosis (67 Child-Pugh Class A; 50 Child-Pugh Class B). Prior to administration of a haemostatic matrix, 93 bleeding sites (24.8{\%}) had a bleeding severity score of 2,269 bleeding sites (71.7{\%}) had a score of 3 and 13 bleeding sites (3.5{\%}) had a score of 4. Following administration of the haemostatic matrix, bleeding stopped completely (score of 0) at 367 (97.9{\%}) of the 375 sites and was reduced to a score of 1 at the remaining 8 sites (2.1{\%}), of which only 2 were in patients with coagulopathy. The mean time to achieve haemostasis in the overall population was 2.9 ± 1 min; this was significantly increased in patients with coagulopathy versus non-coagulopathic patients (4 ± 1 vs. 2 ± 1 min, p <0.001). Conclusions: In this prospective, uncontrolled study of 237 consecutive patients undergoing major hepatic surgery to remove primary or metastatic tumours, application of a haemostatic matrix provided rapid and effective intraoperative control of mild to severe bleeding from the liver edge, even in patients with prolonged bleeding times resulting from cirrhosis. This preliminary evidence warrants a randomised, controlled clinical trial with a larger sample size.",
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AU - Izzo, Francesco

AU - Di Giacomo, Raimondo

AU - Falco, Paolo

AU - Piccirillo, Mauro

AU - Iodice, Rossana

AU - Orlando, Antonio Pio

AU - Aprea, Pasquale

AU - Cremona, Francesco

AU - Di Marzo, Massimiliano

AU - Idà, Domenico Nicola

AU - Mastro, Angelo A.

AU - Curley, Steven A.

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N2 - Background: The haemostatic matrix (FloSeal*) is a topical agent that provides effective haemostasis in a range of surgical applications. We evaluated this sealant for intraoperative haemostatic effectiveness in an observational series of patients undergoing surgery for the resection of primary and metastatic liver tumours. Methods: A haemostatic matrix was applied directly to areas of bleeding. The severity of bleeding before and after application was graded on a 5-point scale (0 = no bleeding, 1 = oozing, 2 = moderate blood flow, 3 = heavy blood flow, 4 = spurting blood). The time to complete haemostasis was also recorded. Results: 105 women (age 61 ± 9 years) and 132 men (age 61 ± 12 years) were included in this study. One hundred and seventeen patients (49.36%) had pre-operative coagulopathy resulting from co-existent cirrhosis (67 Child-Pugh Class A; 50 Child-Pugh Class B). Prior to administration of a haemostatic matrix, 93 bleeding sites (24.8%) had a bleeding severity score of 2,269 bleeding sites (71.7%) had a score of 3 and 13 bleeding sites (3.5%) had a score of 4. Following administration of the haemostatic matrix, bleeding stopped completely (score of 0) at 367 (97.9%) of the 375 sites and was reduced to a score of 1 at the remaining 8 sites (2.1%), of which only 2 were in patients with coagulopathy. The mean time to achieve haemostasis in the overall population was 2.9 ± 1 min; this was significantly increased in patients with coagulopathy versus non-coagulopathic patients (4 ± 1 vs. 2 ± 1 min, p <0.001). Conclusions: In this prospective, uncontrolled study of 237 consecutive patients undergoing major hepatic surgery to remove primary or metastatic tumours, application of a haemostatic matrix provided rapid and effective intraoperative control of mild to severe bleeding from the liver edge, even in patients with prolonged bleeding times resulting from cirrhosis. This preliminary evidence warrants a randomised, controlled clinical trial with a larger sample size.

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