Skip to main content
Journal cover image

Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale.

Publication ,  Journal Article
Ardehali, A; Spotnitz, WD; Hoffman, RW; Olson, SA; Bochicchio, GV; Hermann, MC; Lakshman, S; Dang, NC; Centis, V; Gillen, DL; Schorn, IJ ...
Published in: J Card Surg
January 2019

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.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

J Card Surg

DOI

EISSN

1540-8191

Publication Date

January 2019

Volume

34

Issue

1

Start / End Page

50 / 62

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Thrombin
  • Prospective Studies
  • Postoperative Hemorrhage
  • Middle Aged
  • Male
  • Humans
  • Hemostatics
  • Gelatin Sponge, Absorbable
  • Follow-Up Studies
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Ardehali, A., Spotnitz, W. D., Hoffman, R. W., Olson, S. A., Bochicchio, G. V., Hermann, M. C., … Advanced Powder Investigators Group (APIG). (2019). Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale. J Card Surg, 34(1), 50–62. https://doi.org/10.1111/jocs.13982
Ardehali, Abbas, William D. Spotnitz, Rachel W. Hoffman, Steven A. Olson, Grant V. Bochicchio, Mark C. Hermann, Shankar Lakshman, et al. “Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale.J Card Surg 34, no. 1 (January 2019): 50–62. https://doi.org/10.1111/jocs.13982.
Ardehali A, Spotnitz WD, Hoffman RW, Olson SA, Bochicchio GV, Hermann MC, et al. Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale. J Card Surg. 2019 Jan;34(1):50–62.
Ardehali, Abbas, et al. “Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale.J Card Surg, vol. 34, no. 1, Jan. 2019, pp. 50–62. Pubmed, doi:10.1111/jocs.13982.
Ardehali A, Spotnitz WD, Hoffman RW, Olson SA, Bochicchio GV, Hermann MC, Lakshman S, Dang NC, Centis V, Gillen DL, Schorn IJ, Spotnitz RH, Advanced Powder Investigators Group (APIG). Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale. J Card Surg. 2019 Jan;34(1):50–62.
Journal cover image

Published In

J Card Surg

DOI

EISSN

1540-8191

Publication Date

January 2019

Volume

34

Issue

1

Start / End Page

50 / 62

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Thrombin
  • Prospective Studies
  • Postoperative Hemorrhage
  • Middle Aged
  • Male
  • Humans
  • Hemostatics
  • Gelatin Sponge, Absorbable
  • Follow-Up Studies