Abbas Ardehali1, William D Spotnitz2,3, Rachel W Hoffman4, Steven A Olson5, Grant V Bochicchio6, Mark C Hermann7, Shankar Lakshman8, Nick C Dang9, Valerie Centis10, Dan L Gillen11, Ian J Schorn4, Russell H Spotnitz3. 1. Department of Surgery, University of California at Los Angeles, Los Angeles, California. 2. Department of Surgery, University of Virginia, Charlottesville, Virginia. 3. Department of Medical Affairs, Biom'up, Lyon, France. 4. NAMSA, Clinical and Consulting, Minneapolis, Minnesota. 5. Department of Orthopaedic Surgery, Duke University School of Medicine, Durham, North Carolina. 6. Department of Surgery, Washington University School of Medicine, St. Louis, Missouri. 7. General Orthopedics and Surgery, Spectrum Medical, Danville, Virginia. 8. Department of Surgery, Huntington Hospital, Pasadena, California. 9. Department of Surgery, Queens Hospital, Honolulu, Hawaii. 10. Department of Research and Development, Biom'up, Lyon, France. 11. Department of Statistics, Department of Epidemiology, University of California at Irvine, Irvine, California.
Abstract
AIMS OF THE STUDY: The safety and efficacy of a hemostatic powder (HP) versus a control agent, absorbable gelatin sponge and thrombin (G + T), were assessed, using a validated, quantitative bleeding severity scale. METHODS: Subjects were randomized to receive HP (256 subjects) or G + T (132 subjects) for treatment of minimal, mild, or moderate bleeding at 20 investigational sites. The primary efficacy endpoint was non-inferiority of HP relative to G + T for success at achieving hemostasis within 6 minutes. Secondary endpoints in rank order included: superiority of HP relative to G + T in mean preparation time; non-inferiority of HP relative to G + T for achieving hemostasis within 3 min; superiority of HP relative to G + T for achieving hemostasis within 6 min; and superiority of HP relative to G + T for success for achieving hemostasis within 3 min. RESULTS: A total of 388 subjects were included in the primary efficacy analysis. At 6 min, hemostasis was achieved in 93.0% (238/256) of the HP group compared to 77.3% (102/132) of the G + T group (non-inferiority P < 0.0001, superiority P < 0.0001). All secondary endpoints were met. Complications were comparable between treatment groups. CONCLUSIONS: HP had superior rates of hemostasis, shorter preparation time, and a similar safety profile compared to G + T in this prospective, randomized trial using quantitative bleeding severity criteria.
RCT Entities:
AIMS OF THE STUDY: The safety and efficacy of a hemostatic powder (HP) versus a control agent, absorbable gelatin sponge and thrombin (G + T), were assessed, using a validated, quantitative bleeding severity scale. METHODS: Subjects were randomized to receive HP (256 subjects) or G + T (132 subjects) for treatment of minimal, mild, or moderate bleeding at 20 investigational sites. The primary efficacy endpoint was non-inferiority of HP relative to G + T for success at achieving hemostasis within 6 minutes. Secondary endpoints in rank order included: superiority of HP relative to G + T in mean preparation time; non-inferiority of HP relative to G + T for achieving hemostasis within 3 min; superiority of HP relative to G + T for achieving hemostasis within 6 min; and superiority of HP relative to G + T for success for achieving hemostasis within 3 min. RESULTS: A total of 388 subjects were included in the primary efficacy analysis. At 6 min, hemostasis was achieved in 93.0% (238/256) of the HP group compared to 77.3% (102/132) of the G + T group (non-inferiority P < 0.0001, superiority P < 0.0001). All secondary endpoints were met. Complications were comparable between treatment groups. CONCLUSIONS: HP had superior rates of hemostasis, shorter preparation time, and a similar safety profile compared to G + T in this prospective, randomized trial using quantitative bleeding severity criteria.
Authors: Daniel J Del Gaizo; William D Spotnitz; Rachel W Hoffman; Mark Christopher Hermann; Linda S Sher; Russell H Spotnitz; Yuri S Genyk; Ian J Schorn; Daniel L Gillen; Bobby L White; Bruce G Miller; Roberto J Manson Journal: Clin Appl Thromb Hemost Date: 2020 Jan-Dec Impact factor: 2.389
Authors: Brian A Bruckner; Uy Ngo; Mahesh Ramchandani; Erik Suarez; Samir Awad; Michael Reardon Journal: J Card Surg Date: 2019-07-26 Impact factor: 1.620
Authors: Joshua A Bloom; Zachary Erlichman; Sina Foroutanjazi; Zhaneta Beqiraj; Michael M Jonczyk; Sarah M Persing; Abhishek Chatterjee Journal: Plast Reconstr Surg Glob Open Date: 2021-08-19