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Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial

OBJECTIVE: A kaolin-based nonresorbable hemostatic gauze, QuikClot Control+, has demonstrated effective hemostasis and safety when used for severe/life-threatening (grade 3/4) internal organ space bleeding. We evaluated the efficacy and safety of this gauze for mild to moderate (grade 1-2) bleeding...

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Autores principales: Mumtaz, Mubashir, Thompson, Richard B., Moon, Marc R., Sultan, Ibrahim, Reece, T. Brett, Keeling, William B., DeLaRosa, Jacob
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10328980/
https://www.ncbi.nlm.nih.gov/pubmed/37425449
http://dx.doi.org/10.1016/j.xjon.2023.03.016
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author Mumtaz, Mubashir
Thompson, Richard B.
Moon, Marc R.
Sultan, Ibrahim
Reece, T. Brett
Keeling, William B.
DeLaRosa, Jacob
author_facet Mumtaz, Mubashir
Thompson, Richard B.
Moon, Marc R.
Sultan, Ibrahim
Reece, T. Brett
Keeling, William B.
DeLaRosa, Jacob
author_sort Mumtaz, Mubashir
collection PubMed
description OBJECTIVE: A kaolin-based nonresorbable hemostatic gauze, QuikClot Control+, has demonstrated effective hemostasis and safety when used for severe/life-threatening (grade 3/4) internal organ space bleeding. We evaluated the efficacy and safety of this gauze for mild to moderate (grade 1-2) bleeding in cardiac surgery compared with control gauze. METHODS: This was a randomized, controlled, single-blinded study of patients who underwent cardiac surgery between June 2020 and September 2021 across 7 sites with 231 subjects randomized 2:1 to QuikClot Control+ or control. The primary efficacy end point was hemostasis rate (ie, subjects achieving grade 0 bleed) through up to 10 minutes of bleeding site application, assessed using a semiquantitative validated bleeding severity scale tool. The secondary efficacy end point was the proportion of subjects achieving hemostasis at 5 and 10 minutes. Adverse events, assessed up to 30 days postsurgery, were compared between arms. RESULTS: The predominant procedure was coronary artery bypass grafting, and 69.7% and 29.4% were sternal edge and surgical site (suture line)/other bleeds, respectively. Of the QuikClot Control+ subjects, 121 of 153 (79.1%) achieved hemostasis within 5 minutes, compared with 45 of 78 (58.4%) controls (P < .001). At 10 minutes, 137 of 153 patients (89.8%) achieved hemostasis compared with 52 of 78 controls (68.4%) (P < .001). At 5 and 10 minutes, hemostasis was achieved in 20.7% and 21.4% more QuikClot Control+ subjects, respectively, compared with controls (P < .001). There were no significant differences in safety or adverse events between treatment arms. CONCLUSIONS: QuikClot Control+ demonstrated superior performance in achieving hemostasis for mild to moderate cardiac surgery bleeding compared with control gauze. The proportion of subjects achieving hemostasis was more than 20% higher in QuikClot Control+ subjects at both timepoints compared with controls, with no significant difference in safety outcomes.
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spelling pubmed-103289802023-07-09 Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial Mumtaz, Mubashir Thompson, Richard B. Moon, Marc R. Sultan, Ibrahim Reece, T. Brett Keeling, William B. DeLaRosa, Jacob JTCVS Open Coronary: Clinical Trial OBJECTIVE: A kaolin-based nonresorbable hemostatic gauze, QuikClot Control+, has demonstrated effective hemostasis and safety when used for severe/life-threatening (grade 3/4) internal organ space bleeding. We evaluated the efficacy and safety of this gauze for mild to moderate (grade 1-2) bleeding in cardiac surgery compared with control gauze. METHODS: This was a randomized, controlled, single-blinded study of patients who underwent cardiac surgery between June 2020 and September 2021 across 7 sites with 231 subjects randomized 2:1 to QuikClot Control+ or control. The primary efficacy end point was hemostasis rate (ie, subjects achieving grade 0 bleed) through up to 10 minutes of bleeding site application, assessed using a semiquantitative validated bleeding severity scale tool. The secondary efficacy end point was the proportion of subjects achieving hemostasis at 5 and 10 minutes. Adverse events, assessed up to 30 days postsurgery, were compared between arms. RESULTS: The predominant procedure was coronary artery bypass grafting, and 69.7% and 29.4% were sternal edge and surgical site (suture line)/other bleeds, respectively. Of the QuikClot Control+ subjects, 121 of 153 (79.1%) achieved hemostasis within 5 minutes, compared with 45 of 78 (58.4%) controls (P < .001). At 10 minutes, 137 of 153 patients (89.8%) achieved hemostasis compared with 52 of 78 controls (68.4%) (P < .001). At 5 and 10 minutes, hemostasis was achieved in 20.7% and 21.4% more QuikClot Control+ subjects, respectively, compared with controls (P < .001). There were no significant differences in safety or adverse events between treatment arms. CONCLUSIONS: QuikClot Control+ demonstrated superior performance in achieving hemostasis for mild to moderate cardiac surgery bleeding compared with control gauze. The proportion of subjects achieving hemostasis was more than 20% higher in QuikClot Control+ subjects at both timepoints compared with controls, with no significant difference in safety outcomes. Elsevier 2023-05-04 /pmc/articles/PMC10328980/ /pubmed/37425449 http://dx.doi.org/10.1016/j.xjon.2023.03.016 Text en © 2023 The Author(s) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Coronary: Clinical Trial
Mumtaz, Mubashir
Thompson, Richard B.
Moon, Marc R.
Sultan, Ibrahim
Reece, T. Brett
Keeling, William B.
DeLaRosa, Jacob
Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial
title Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial
title_full Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial
title_fullStr Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial
title_full_unstemmed Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial
title_short Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial
title_sort safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: a randomized trial
topic Coronary: Clinical Trial
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10328980/
https://www.ncbi.nlm.nih.gov/pubmed/37425449
http://dx.doi.org/10.1016/j.xjon.2023.03.016
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