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Hemostatic efficacy of latest-generation fibrin sealant after hepatic resection: a randomized controlled clinical study

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Abstract

Purpose

This randomized, controlled, single-blinded multicenter study evaluated the efficacy of latest-generation fibrin sealant containing synthetic aprotinin as fibrinolysis inhibitor as supportive treatment for hemostasis after elective partial hepatectomy.

Methods

Adult subjects undergoing resection of at least one liver segment were assigned to treatment with fibrin sealant or manual compression with a surgical gauze swab if persistent oozing necessitated additional hemostatic measures after primary control of arterial and venous bleeding. The primary outcome measure was the proportion of subjects with intraoperative hemostasis at 4 min after start of randomized treatment application. Secondary efficacy outcome measures included intraoperative hemostasis at 6, 8, and 10 min, intra- and postoperative rebleedings, transfusion requirements, and drainage volume.

Results

Seventy subjects were randomized. Hemostasis at 4 min was achieved in 29/35 (82.9 %) fibrin sealant subjects compared with 13/35 (37.1 %) control subjects (p < 0.001). Significantly more fibrin sealant subjects achieved hemostasis at 6 (p < 0.001), 8 (p = 0.028), and 10 min (p = 0.017). The number of rebleedings was low in both study arms. Transfusion requirements and 48-h drainage volumes were similar between the study arms. No adverse events related to study treatment were reported.

Conclusions

Fibrin sealant was shown to be safe and superior to manual compression in the control of parenchymal bleeding after hepatic resection. The use of synthetic aprotinin as fibrinolysis inhibitor further improves the safety margin of fibrin sealant by eliminating the risk of transmission of bovine spongiform encephalopathy and other bovine pathogens.

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Acknowledgments

The following principal investigators and centers participated in the study (in alphabetical order): Hüseyin Bektas, MD, Medical University of Hannover, Clinic for General, Visceral and Transplant Surgery, D-30625 Hannover, Germany; Markus Buechler, MD who as principal investigator followed Jan Schmidt, MD, University of Heidelberg Surgical Clinic, Clinic for General, Visceral and Transplant Surgery, D-69120 Heidelberg, Germany; Sven Jonas, MD, University Clinic of Leipzig, Clinic for Visceral, Transplant, Thorax and Vascular Surgery, D-04103 Leipzig, Germany; Gernot Kaiser, MD, University Clinic of Essen, Clinic for General and Transplant Surgery, D-45147 Essen, Germany; Silvio Nadalin, MD, Eberhard Karls University of Tuebingen, Clinic for General, Visceral and Transplant Surgery, D-72076 Tuebingen, Germany; Daniel Seehofer, MD, Charité-Medical University of Berlin, Clinic for General, Visceral and Transplant Surgery, D-13353 Berlin, Germany; and Utz Settmacher, MD, University Clinic of Jena, Clinic for General, Visceral and Vascular Surgery, D-07747 Jena, Germany. This clinical research was sponsored by Baxter Innovations GmbH, Vienna, Austria.

Conflicts of interest

None.

Author information

Author notes

  1. Jan Schmidt

    Present address: Hirslanden Clinics Zurich, 8032, Zurich, Switzerland

Authors and Affiliations

  1. Clinic for General, Visceral and Transplant Surgery, Medical University of Hannover, 30625, Hannover, Germany

    Hüseyin Bektas

  2. Clinic for General, Visceral and Transplant Surgery, Eberhard Karls University of Tuebingen, 72076, Tübingen, Germany

    Silvio Nadalin

  3. Baxter Innovations GmbH, Industriestrasse 67, 1220, Vienna, Austria

    Ildiko Szabo, Bettina Ploder & Marlies Sharkhawy

  4. Clinic for General, Visceral and Transplant Surgery, University of Heidelberg Surgical Clinic, 69120, Heidelberg, Germany

    Jan Schmidt

Authors
  1. Hüseyin Bektas
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  2. Silvio Nadalin
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  3. Ildiko Szabo
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  4. Bettina Ploder
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  5. Marlies Sharkhawy
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  6. Jan Schmidt
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Corresponding author

Correspondence to Marlies Sharkhawy.

Additional information

The study was registered under ClinicalTrials.gov identifier NCT01244425.

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Bektas, H., Nadalin, S., Szabo, I. et al. Hemostatic efficacy of latest-generation fibrin sealant after hepatic resection: a randomized controlled clinical study. Langenbecks Arch Surg 399, 837–847 (2014). https://doi.org/10.1007/s00423-014-1227-1

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  • DOI: https://doi.org/10.1007/s00423-014-1227-1

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