Efficacy of Different Hemostatic Devices for Severe Liver Bleeding: A Randomized Controlled Animal Study

Takács, Ildikó; Wegmann, Jürgen; Horvath, Szabolcs; Ferencz, Andrea; Ferencz, A.; Jávor, Szaniszló; Odermatt, Erich K.; Róth, Ernst; Wéber, György

doi:10.1177/1553350610384405

Cited by 16 publications

(14 citation statements)

References 30 publications

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“…In a head-to-head trial, TachoSil was compared with a regenerated oxidized cellulose compress (Surgicel, Johnson and Johnson, Somerville, NJ) and a bovine collagen-based compress (Sangustop, B. Braun Aesculap AG, Tuttlingen, Germany) [28]. Liver resection margins were created in a swine model and each of the three compresses applied to different areas of resection margin.…”

Section: Resultsmentioning

confidence: 99%

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

et al. 2012

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Background. Despite progress in surgical techniques applied during hepatobiliary and pancreas (HPB) surgery, bleeding and bile leak remain significant contributors to postoperative mortality and morbidity. Topical hemostatics have been developed and utilized across surgical specialties, but data regarding effectiveness remains inconsistent and sparse in HPB surgery. Methods. A comprehensive search for studies and reviews on hemostatics in HPB surgery was performed via an October 2011 query of Medline, EMBASE, and Cochrane Library. In-depth evaluation of a novel carrier-bound fibrin sealant (TachoSil) was also performed. Results. The literature review illustrates multiple attempts have been made at developing different topical hemostatics and sealants to aid in surgical procedures. In HPB surgery, efforts have been directed at decreasing bleeding, biliary leakage, and pancreatic fistula. Conflicting scientific evidence exists regarding the effectiveness of these agents. Critical evaluation of the literature demonstrates TachoSil is a valuable tool in achieving hemostasis, and possibly biliostasis and pancreatic fistula prevention. Conclusion. While progress has been made in topical hemostatics for HPB surgery, an ideal agent has not yet been identified. TachoSil is promising, but larger randomized, controlled clinical trials are required to more fully evaluate its efficacy in reducing bleeding, biliary leakage, and pancreatic fistulas in HPB surgery.

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Section: Resultsmentioning

confidence: 99%

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

et al. 2012

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“…In a study on bovine, Takács et al [16] observed less time to hemostasis in TachoSil in comparison to Surgicel. In our study, bleeding after hemostasis and mean first postoperative day blood drainage volume in TachoSil were significantly lower than Surgicel.…”

Section: Discussionmentioning

confidence: 99%

A Randomized Clinical Trial Comparing the Effect of Different Haemostatic Agents for Haemostasis of the Liver after Hepatic Resection

et al. 2013

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Introduction. Operative blood loss is still a great obstacle to liver resection, and various topical hemostatic agents were introduced to reduce it. The aim of the current study is to evaluate effects of 3 different types of these agents. Methods. In this randomized clinical trial, 45 patients undergoing liver resection were assigned to receive TachoSil, Surgicel, and Glubran 2 for controlling bleeding. Intraoperative and postoperative findings were compared between groups. Results. Postoperative bleeding (0 versus 33.3%, P = 0.04) and drainage volume first day after surgery (281.33 ± 103.98 versus 150.00 ± 60.82 mL, P = 0.02) were significantly higher in Surgicel than in TachoSil group. Postoperative complications included bile leak (3 cases in Surgicel, 1 case in TachoSil and Glubran 2), noninfectious collection (2 cases in TachoSil and Surgicel and 1 case in Glubran 2), perihepatic abscess, and massive hematoma around hepatectomy site both in Surgicel group. There was no death during the study period. Conclusion. Due to higher complications in Surgicel group, its application as hemostatic agent after liver resection is not recommended. Better results in TachoSil in comparison to the other two are indicative of its better efficacy and superiority in controlling hemostasis.

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“…Assuming a drop-out rate of 5 %, a total number of 126 patients are needed to be enrolled. The expected difference of 15 % was justified by preclinical data [20]. …”

Section: Methodsmentioning

confidence: 99%

Randomized controlled multicenter trial on the effectiveness of the collagen hemostat Sangustop® compared with a carrier-bound fibrin sealant during liver resection (ESSCALIVER study, NCT00918619)

Moench

Mihaljevic

Hermanutz³

et al. 2014

Langenbecks Arch Surg

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BackgroundDespite improvements in liver surgery over the past decades, hemostasis during hepatic resections remains challenging. This multicenter randomized study compares the hemostatic effect of a collagen hemostat vs. a carrier-bound fibrin sealant after hepatic resection.MethodsPatients scheduled for elective liver resection were randomized intraoperatively to receive either the collagen hemostat (COLL) or the carrier-bound fibrin sealant (CBFS) for secondary hemostasis. The primary endpoint was the proportion of patients with hemostasis after 3 min. Secondary parameters were the proportions of patients with hemostasis after 5 and 10 min, the total time to hemostasis, and the complication rates during a 3 months follow-up period.ResultsA total of 128 patients were included. In the COLL group, 53 out of 61 patients (86.9 %) achieved complete hemostasis within 3 min after application of the hemostat compared to 52 out of 65 patients (80.0 %) in the CBFS group. The 95 % confidence interval for this difference [−6.0 %, 19.8 %] does not include the lower noninferiority margin (−10 %). Thus, the COLL treatment can be regarded as noninferior to the comparator. The proportions of patients with hemostasis after 3, 5, and 10 min were not significantly different between the two study arms. Postoperative mortality and morbidity were similar in both treatment groups.ConclusionThe collagen hemostat is as effective as the carrier-bound fibrin sealant in obtaining secondary hemostasis during liver resection with a comparable complication rate.Electronic supplementary materialThe online version of this article (doi:10.1007/s00423-014-1203-9) contains supplementary material, which is available to authorized users.

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Efficacy of Different Hemostatic Devices for Severe Liver Bleeding: A Randomized Controlled Animal Study

Abstract: BoCo showed significantly better hemostatic effect than PECo and OxCe.

Cited by 16 publications

References 30 publications

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

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

A Randomized Clinical Trial Comparing the Effect of Different Haemostatic Agents for Haemostasis of the Liver after Hepatic Resection

Randomized controlled multicenter trial on the effectiveness of the collagen hemostat Sangustop® compared with a carrier-bound fibrin sealant during liver resection (ESSCALIVER study, NCT00918619)

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