TY - JOUR
T1 - Evaluation of the Safety and Efficacy of a Novel Thrombin Containing Combination Hemostatic Powder Using a Historical Control
AU - Bruckner, Brian A.
AU - Spotnitz, William D.
AU - Suarez, Erik
AU - Loebe, Matthias
AU - Ngo, Uy
AU - Gillen, Daniel L.
AU - Manson, Roberto J.
N1 - Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The development of this manuscript was supported by Biom’Up France, SAS.
Publisher Copyright:
© The Author(s) 2021.
PY - 2021
Y1 - 2021
N2 - This clinical study compares 2 hemostatic agents, a novel combination powder (CP) (HEMOBLAST™ Bellows) and an established polysaccharide starch powder (PP) (Arista™ AH) to assess the usefulness of CP. Retrospective comparative analysis of CP (July 2018 to July 2019, 68 patients) to PP (January 2011 to January 2013, 94 patients) in cardiothoracic patients was performed using linear regression models adjusting for age, sex, and procedure type for the endpoints: blood loss; protamine to skin closure time (hemostasis time); chest tube output and blood products required 48 hours postoperatively; ICU stay; postoperative comorbidities; and 30 day mortality. 162 patients (108 M: 54 F) underwent 162 cardiothoracic surgical procedures including: transplantation (n = 44), placement of ventricular assist device (n = 87), and others (n = 31). Use of CP compared to PP (Estimated Mean Difference [95% CI], P-value) produced significant reductions: blood loss (mL) (−886.51 [−1457.76, −312.26], P = 0.003); protamine to skin closure time (min) (−16.81 [−28.03, −5.59], P = 0.004); chest tube output (48 hrs, mL) (−445.76 [−669.38, −222.14], P < 0.001); packed red blood cell transfusions (units) (−0.98 [−1.56, −0.4], P = 0.001); and postoperative comorbidities (−0.31 [−0.55, −0.07], P = 0.012). There were no differences in the ICU stay (4.07 [−2.01, 10.15], P = 0.188) or 30-day mortality (0.57 [0.20, 1.63], P = 0.291). The use of CP in complex cardiothoracic operations resulted in improved hemostasis and significant clinical benefits in blood loss, transfusion requirements, morbidity, and time in operating room.
AB - This clinical study compares 2 hemostatic agents, a novel combination powder (CP) (HEMOBLAST™ Bellows) and an established polysaccharide starch powder (PP) (Arista™ AH) to assess the usefulness of CP. Retrospective comparative analysis of CP (July 2018 to July 2019, 68 patients) to PP (January 2011 to January 2013, 94 patients) in cardiothoracic patients was performed using linear regression models adjusting for age, sex, and procedure type for the endpoints: blood loss; protamine to skin closure time (hemostasis time); chest tube output and blood products required 48 hours postoperatively; ICU stay; postoperative comorbidities; and 30 day mortality. 162 patients (108 M: 54 F) underwent 162 cardiothoracic surgical procedures including: transplantation (n = 44), placement of ventricular assist device (n = 87), and others (n = 31). Use of CP compared to PP (Estimated Mean Difference [95% CI], P-value) produced significant reductions: blood loss (mL) (−886.51 [−1457.76, −312.26], P = 0.003); protamine to skin closure time (min) (−16.81 [−28.03, −5.59], P = 0.004); chest tube output (48 hrs, mL) (−445.76 [−669.38, −222.14], P < 0.001); packed red blood cell transfusions (units) (−0.98 [−1.56, −0.4], P = 0.001); and postoperative comorbidities (−0.31 [−0.55, −0.07], P = 0.012). There were no differences in the ICU stay (4.07 [−2.01, 10.15], P = 0.188) or 30-day mortality (0.57 [0.20, 1.63], P = 0.291). The use of CP in complex cardiothoracic operations resulted in improved hemostasis and significant clinical benefits in blood loss, transfusion requirements, morbidity, and time in operating room.
KW - combination hemostat
KW - efficacy
KW - hemostasis
KW - powder
KW - safety
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U2 - 10.1177/10760296211017238
DO - 10.1177/10760296211017238
M3 - Article
C2 - 34024165
AN - SCOPUS:85106673824
VL - 27
JO - Clinical and Applied Thrombosis/Hemostasis
JF - Clinical and Applied Thrombosis/Hemostasis
SN - 1076-0296
ER -