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Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale.
- Source :
-
Journal of cardiac surgery [J Card Surg] 2019 Jan; Vol. 34 (1), pp. 50-62. Date of Electronic Publication: 2019 Jan 10. - Publication Year :
- 2019
-
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.<br />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.<br />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.<br />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.<br /> (© 2019 The Authors. Journal of Cardiac Surgery Published by Wiley Periodicals, Inc.)
Details
- Language :
- English
- ISSN :
- 1540-8191
- Volume :
- 34
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Journal of cardiac surgery
- Publication Type :
- Academic Journal
- Accession number :
- 30629770
- Full Text :
- https://doi.org/10.1111/jocs.13982