Evaluation of Hemostatic Powder Safety & Efficacy PDF

DOI: 10.1111/jocs.13982 NEW TECHNOLOGIES Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale Abbas Ardehali MD1 | William D. Spotnitz MD2,3 | Rachel W. Hoffman BSE4 | Steven A. Olson MD5 | Grant V....

DOI: 10.1111/jocs.13982 NEW TECHNOLOGIES Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale Abbas Ardehali MD1 | William D. Spotnitz MD2,3 | Rachel W. Hoffman BSE4 | Steven A. Olson MD5 | Grant V. Bochicchio MD6 | Mark C. Hermann MD7 | Shankar Lakshman MD8 | Nick C. Dang MD9 | Valerie Centis PhD10 | Dan L. Gillen PhD11 | Ian J. Schorn BSE4 | Russell H. Spotnitz MD3 | the Advanced Powder Investigators Group (APIG)12 1 Department of Surgery, University of California at Los Angeles, Los Angeles, Abstract California Aims of the study: The safety and efficacy of a hemostatic powder (HP) versus a control 2 Department of Surgery, University of Virginia, Charlottesville, Virginia agent, absorbable gelatin sponge and thrombin (G + T), were assessed, using a 3 Department of Medical Affairs, Biom’up, validated, quantitative bleeding severity scale. Lyon, France Methods: Subjects were randomized to receive HP (256 subjects) or G + T (132 4 NAMSA, Clinical and Consulting, Minneapolis, Minnesota subjects) for treatment of minimal, mild, or moderate bleeding at 20 investigational 5 Department of Orthopaedic Surgery, Duke sites. The primary efficacy endpoint was non-inferiority of HP relative to G + T for University School of Medicine, Durham, North success at achieving hemostasis within 6 minutes. Secondary endpoints in rank order Carolina 6 Department included: superiority of HP relative to G + T in mean preparation time; non-inferiority of of Surgery, Washington University School of Medicine, St. Louis, HP relative to G + T for achieving hemostasis within 3 min; superiority of HP relative to Missouri Advanced Powder Investigators Group (APIG) Members: Gorav Ailawadi, MD, TCV Surgery, University of Virginia, Charlottesville, VA; Michael Argenziano, MD, Adult Cardiac Surgery Section, New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; Guarav Bharti, MD, Plastic Surgery, Hunstad Kortesis Bharti Cosmetic Surgery, Huntersville, NC; Michael A. Borger, MD, Aortic Surgery Section, New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; William C. Chapman, MD, Section of Transplantation, Washington University School of Medicine, St. Louis, MO; Philip C. Corcoran, MD, Cardiothoracic Surgery, NIH Heart Center at Suburban Hospital, Bethesda, MD; Mani A. Daneshmand, MD, Cardiothoracic Surgery, Duke University Medical Center, Durham, NC; Daniel J. Del Gaizo, MD, Department of Orthopaedic Surgery, University of North Carolina School of Medicine, Chapel Hill, NC; Joseph P. DeSimone, MD, and Anthony W. DiScipio, MD, Department of Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH; Maria Bernadette Majella Doyle, MD, Department of Surgery, Washington University School of Medicine, St. Louis, MO; Yuri S. Genyk, MD, Division of Hepatobiliary/Pancreatic Surgery and Abdominal Organ Transplantation, Keck School of Medicine, University of Southern California, Los Angeles, CA; Keith A. Horvath, MD, Cardiothoracic Surgery, NIH Heart Center at Suburban Hospital, Bethesda, MD; Joseph P. Hunstad, MD, Plastic Surgery, Hunstad Kortesis Bharti Cosmetic Surgery, Huntersville, NC; Kareem Daniel Husain, MD, Department of Surgery, Washington University School of Medicine, St. Louis, MO; Obeid N. Ilahi, MD, Department of Surgery, Washington University School of Medicine, St. Louis, MO; Alexander Iribarne, MD, Department of Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH; Michael E. Kelly, MD, Miami Plastic Surgery, Miami, FL; Bill G. Kortesis, MD, Plastic Surgery, Hunstad Kortesis Bharti Cosmetic Surgery, Huntersville, NC; Jeffrey M. Lau, MD, Department of Cardiovascular Medicine, The Queen's Medical Center, Honolulu, HI; Brian D. Lewis, MD, Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC; John S. Mahoney, MD, General Orthopedics and Surgery, Spectrum Medical, Danville, VA; Jock N. McCullough, MD, Department of Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH; Marc R. Moon, MD, Division of Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, MO; Steven L. Myerthall, MD, Orthopedic Surgery, Center for Orthopedic Research and Education, Gilbert, AZ; Nadia M. Obeid, MD, Department of Surgery, Washington University School of Medicine, St. Louis, MO; Max Polo, MD, Plastic Surgery, Miami Plastic Surgery, Miami, FL; Laurie J. Punch, MD, Department of Surgery, Washington University School of Medicine, St. Louis, MO; Ramachandra C. Reddy, MD, Thoracic Surgery, Mount Sinai School of Medicine, New York, NY; Jose Rodriguez-Feliz, MD, Plastic Surgery, Miami Plastic Surgery, Miami, FL; Jacob N. Schroder, MD, Cardiothoracic Surgery, Duke University Medical Center, Durham, NC; Douglas J.E. Schuerer, MD, Department of Surgery, Washington University School of Medicine, St. Louis, MO; Linda S. Sher, MD, Division of Hepatobiliary/Pancreatic Surgery and Abdominal Organ Transplantation, Keck School of Medicine, University of Southern California, Los Angeles, CA; Ivan R. Zendejas-Ruiz, MD, General Surgery, Intermountain Medical Center, Murray, UT. TRIAL REGISTRATION HEMOBLAST Bellows Pivotal Clinical Investigation; clinicaltrials.gov identifier NCT02780869; https://clinicaltrials.gov/ct2/show/NCT02780869 This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2019 The Authors. Journal of Cardiac Surgery Published by Wiley Periodicals, Inc. J Card Surg. 2019;1–13. wileyonlinelibrary.com/journal/jocs | 1 2 | ARDEHALI ET AL. 7 GeneralOrthopedics and Surgery, Spectrum G + T for achieving hemostasis within 6 min; and superiority of HP relative to G + T for Medical, Danville, Virginia 8 Department of Surgery, Huntington Hospital, success for achieving hemostasis within 3 min. Pasadena, California Results: A total of 388 subjects were included in the primary efficacy analysis. At 6 min, 9 Department of Surgery, Queens Hospital, hemostasis was achieved in 93.0% (238/256) of the HP group compared to 77.3% Honolulu, Hawaii 10 Department of Research and Development, (102/132) of the G + T group (non-inferiority P < 0.0001, superiority P < 0.0001). All Biom’up, Lyon, France secondary endpoints were met. Complications were comparable between treatment 11 Department of Statistics, Department of groups. Epidemiology, University of California at Irvine, Irvine, California Conclusions: HP had superior rates of hemostasis, shorter preparation time, and a 12 Advanced Powder Investigators Group similar safety profile compared to G + T in this prospective, randomized trial using (APIG) quantitative bleeding severity criteria. Correspondence William D. Spotnitz MD, MBA, 2738 SW 92nd KEYWORDS Drive, Gainesville, FL 32608. bleeding scale, collagen, hemostat, hemostatic agent, hemostatic powder, thrombin Email: [email protected] Funding information Biom'up 1 | INTRODUCTION Subjects 21 years and older undergoing non-emergent cardiotho- racic, abdominal, and lower extremity orthopedic operations were Level I evidence of the benefit of local hemostats in surgical operations evaluated after providing written informed consent. Subjects were is limited, yet research in this area is continuing to grow.1–39 Although excluded if they met the following criteria: undergoing laparoscopic, the ideal surgical hemostat—one combining safety, efficacy, usability, thoracoscopic, robotic, neurologic, spinal, or emergency surgery; cost, and approvability—has yet to be created, continued development pregnant, planning on becoming pregnant during the follow-up period, work is resulting in new agents.40–42 or actively breast-feeding; platelet count 1.5 within 4 weeks of surgery; receiving intravenous efficacy of a novel hemostatic powder (HP) containing collagen, heparin 12 hr prior to surgery or oral warfarin 2 days prior to surgery; chondroitin sulfate, and thrombin compared to an established receiving antiplatelet medications within 5 days of surgery or aspirin absorbable gelatin sponge and thrombin hemostatic agent.43 This within 7 days of surgery (exception: cardiothoracic subjects could receive multicenter trial compared efficacy based on levels of bleeding using a aspirin at any time before surgery); active or suspected infection at the unique, validated, quantitative surface bleeding severity scale (SBSS), surgical site; planned to receive organ transplantation; known sensitivity the SPOT GRADE.44 This SBSS is a bleeding severity scale based on or allergy to bovine and/or porcine substance(s) or any other component- quantitative measures that has been specifically validated in a clinical (s) of the hemostat; American Society of Anesthesiologists classification of setting.45 Other bleeding severity scales are based on qualitative 5; life expectancy