1. Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale
- Author
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Ian J Schorn, Daniel L. Gillen, Valerie Centis, Grant V. Bochicchio, Shankar Lakshman, Abbas Ardehali, Nick C Dang, Russell H Spotnitz, Steven A. Olson, Mark Christopher Hermann, Rachel W Hoffman, and William D. Spotnitz
- Subjects
Adult ,Male ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,HEMOSTATIC POWDER ,Blood Loss, Surgical ,Postoperative Hemorrhage ,030204 cardiovascular system & hematology ,Gastroenterology ,Hemostatics ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Humans ,Prospective Studies ,Aged ,Aged, 80 and over ,Hemostat ,Absorbable gelatin sponge ,Hemostatic Agent ,business.industry ,Thrombin ,Middle Aged ,Gelatin Sponge, Absorbable ,Safety profile ,Treatment Outcome ,030228 respiratory system ,Hemostasis ,Severity Criteria ,Female ,Surgery ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - Abstract
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.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.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.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.
- Published
- 2019