Purpose <p>We assessed the efficacy and safety of Purastat<sup>®</sup>, a novel synthetic hemostat, for the treatment of exudative hemorrhaging in pulmonary artery (PA) stumps.</p> Methods <p>This single-arm prospective interventional study included eligible patients scheduled for anatomical pulmonary resection. Purastat<sup>®</sup> was applied intraoperatively to patients with exudative hemorrhaging at the PA stump, where hemorrhaging persisted despite 30&#xa0;s of compression following dissection with an automatic suturing device. The primary endpoint was the rate of additional hemostatic treatment required, with a prespecified threshold of 25%. The secondary endpoints included the time to achieve hemostasis, rate of postoperative rebleeding, and adverse events.</p> Results <p>Sixty-four patients were enrolled, and 80 PAs from 56 patients were dissected using an automatic suture device. Exudative hemorrhaging occurred in 31 PA stumps (38.8%), and hemorrhaging persisted after 30&#xa0;s of compression in 23 cases (28.8%) in which Purastat<sup>®</sup> was applied. The rate of additional hemostatic treatment required was 4.35% (95% confidence interval, 0%–19.0%; only 1 patient), meeting the prespecified threshold. The median time to achieve hemostasis was 30.0&#xa0;s. No serious adverse events or postoperative rebleeding was observed.</p> Conclusion <p>Hemostasis with Purastat<sup>®</sup> for exudative hemorrhaging at the PA stumps was effective and had no serious safety concerns.</p>

错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

Efficacy and safety of PuraStat® for exudative hemorrhaging at the pulmonary artery stump

  • Shinya Katsumata,
  • Keigo Matsushima,
  • Hayato Konno,
  • Koki Maeda,
  • Mitsuhiro Isaka,
  • Hideaki Kojima,
  • Kenta Murotani,
  • Miho Naito,
  • Daisuke Yamaguchi,
  • Momoko Asami,
  • Tatsuya Masuda,
  • Kazuki Hayasaka,
  • Naoya Yokomakura,
  • Yasuhisa Ohde

摘要

Purpose

We assessed the efficacy and safety of Purastat®, a novel synthetic hemostat, for the treatment of exudative hemorrhaging in pulmonary artery (PA) stumps.

Methods

This single-arm prospective interventional study included eligible patients scheduled for anatomical pulmonary resection. Purastat® was applied intraoperatively to patients with exudative hemorrhaging at the PA stump, where hemorrhaging persisted despite 30 s of compression following dissection with an automatic suturing device. The primary endpoint was the rate of additional hemostatic treatment required, with a prespecified threshold of 25%. The secondary endpoints included the time to achieve hemostasis, rate of postoperative rebleeding, and adverse events.

Results

Sixty-four patients were enrolled, and 80 PAs from 56 patients were dissected using an automatic suture device. Exudative hemorrhaging occurred in 31 PA stumps (38.8%), and hemorrhaging persisted after 30 s of compression in 23 cases (28.8%) in which Purastat® was applied. The rate of additional hemostatic treatment required was 4.35% (95% confidence interval, 0%–19.0%; only 1 patient), meeting the prespecified threshold. The median time to achieve hemostasis was 30.0 s. No serious adverse events or postoperative rebleeding was observed.

Conclusion

Hemostasis with Purastat® for exudative hemorrhaging at the PA stumps was effective and had no serious safety concerns.