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Safety and Hemostatic Effectiveness of the Fibrin Pad for Severe Soft-Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic (Non-cardiac) Surgery: A Randomized, Controlled, Superiority Trial

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An Erratum to this article was published on 28 July 2015

Abstract

Background

In surgery, rapid hemostasis can be required in various settings and bleeding intensities to minimize complications related to blood loss. While effective hemostats are available for mild-to-moderate surgical bleeding, few are effective against challenging severe hemorrhage. We report the effectiveness and safety of the fibrin pad (FP), a novel combination hemostat (device/human biologic), in controlling severe soft-tissue bleeding as compared to the standard of care (SoC).

Methods

This randomized, controlled, superiority study enrolled subjects ≥18 years, requiring elective abdominal, retroperitoneal, pelvic, or thoracic (non-cardiac) surgery. A severe target bleeding site (TBS) was identified intra-operatively following which, subjects were randomized to the FP or the SoC group. Hemostatic status was observed at 4 min (primary endpoint) and 10 min post-randomization. Safety variables included TBS-related bleeding and thrombotic events.

Results

At 4 min post-randomization, 50/59 (84.7 %) subjects in the FP group and 16/32 (50 %) subjects in the SoC group achieved hemostasis without needing re-treatment (P < 0.0001). Compared to the SoC group, the FP group showed better hemostasis at 10 min post-randomization [58/59 (98.3 %) vs. 28/32 (87.5 %); P = 0.01], lower mean time to hemostasis (6.1 ± 13.5 vs. 17.8 ± 32.0 min), and a less frequent need for re-treatment (5.1 vs. 53.1 %). The triangular test for binary response demonstrated the FP to be superior to SoC (95 % CI 1.474–3.290; P < 0.0001). Safety profiles in both groups were similar to those typically observed after long-duration surgery.

Conclusion

The FP is safe and superior to SoC for controlling challenging severe soft-tissue bleeding encountered during intra-abdominal and thoracic surgical procedures.

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Acknowledgments

Fibrin pads were provided by Omrix Biopharmaceuticals, Ltd., Kiryat Ono, Israel. The authors retained full control of the manuscript content. The authors acknowledge the contribution of the following clinical development staff: Val Jarvis-Evans, Anna Lam, Gerry Leighton, Nicolas Aguirre, Cristina Dyogi, David Shah, and Linda Lin. The following centers and investigators contributed subjects to this trial: United Kingdom: Peter Baldwin MD, Addenbrooke’s Hospital, Cambridge (Regional Coordinating Investigator); Mr Justin Davis, Addenbrooke’s Hospital, Cambridge (Colorectal Surgeon); Emmanuel Huguet, Addenbrooke’s Hospital, Cambridge (HPB/Transplant Surgeon); Ernest Hidalgo MD, Royal Infirmary of Edinburgh, Edinburgh; Owen Cole MD, Nottingham City Hospital, Nottingham; and Kostas Papagiannopoulos MD, St. James University Hospital, Leeds. Germany: Joerg Mezger MD, Vincentius-Kliniken, Karlsruhe; Moritz von Frankenberg MD, Krankenhaus Salem, Heidelberg; Martin Schilling MD, University of Saarland Homburg, Saar; and Christoph Seiler MD, University of Heidelberg, Heidelberg. New Zealand: Jonathan Koea MD, Auckland City Hospital, Auckland (Regional Coordinating Investigator); Michael Rodgers MD, North Shore Hospital, Auckland; and Grant Beban MD, Auckland Gastroenterology Associates, Epsom, Auckland. Australia: Anthony Costello MD, Royal Melbourne Hospital, Parkville, Melbourne, Victoria; Ajay Rane MD, The Townsville Hospital, Townsville, Queensland; Robert Padbury MD, Flinders Medical Centre, Bedford Park, Adelaide, South Australia; and Neil Merrett MD, Bankstown Hospital, Bankstown, Sydney, New South Wales. The contribution of the medical staff, nursing staff, theater staff, and intensive care staff as well as the trial coordinators in each of these centers is gratefully acknowledged.

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Authors and Affiliations

  1. Department of Surgery, Auckland City Hospital, Grafton, New Zealand

    Jonathan Koea

  2. Addenbrooke’s Hospital, Cambridge, UK

    Peter Baldwin

  3. Ethicon, Inc., Somerville, NJ, USA

    Jessica Shen, B. Patel, Jonathan Batiller, Axel Arnaud, James Hart & Jeffrey Hammond

  4. Weill Cornell Medical College of Cornell University, Houston, TX, USA

    Craig Fischer

  5. Royal Infirmary of Edinburgh, Edinburgh, UK

    O. James Garden

  6. Department of Surgery, North Shore Hospital, Private Bag 93505, Auckland, 0620, New Zealand

    Jonathan Koea

Authors
  1. Jonathan Koea
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  2. Peter Baldwin
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  3. Jessica Shen
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  4. B. Patel
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  5. Jonathan Batiller
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  6. Axel Arnaud
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  7. James Hart
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  8. Jeffrey Hammond
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  9. Craig Fischer
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  10. O. James Garden
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Corresponding author

Correspondence to Jonathan Koea.

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Koea, J., Baldwin, P., Shen, J. et al. Safety and Hemostatic Effectiveness of the Fibrin Pad for Severe Soft-Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic (Non-cardiac) Surgery: A Randomized, Controlled, Superiority Trial. World J Surg 39, 2663–2669 (2015). https://doi.org/10.1007/s00268-015-3106-5

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  • DOI: https://doi.org/10.1007/s00268-015-3106-5

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