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

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. 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.

The SPOT GRADE II: Clinical Validation of a New Method for Reproducibly Quantifying Surgical Wound Bleeding

“…[29,30] The SPOT GRADE (SG) is a clinically validated surface bleeding severity scale (SBSS) that was developed for the quantitative assessment of target bleeding site (TBS) blood loss ( Figure 1) and meets regulatory agency requirements for use. [31,32,33] In addition to providing a consistent and reliable method for evaluating hemostatic agent performance, another potential bene t of the SG scale in surgery is to serve as an indicator of severity and volume of blood loss prior to systemic blood pressure changes and reductions in hematocrit. Having a consistent, uniform scale for bleeding severity may allow further de nition and delineation of appropriate actions to minimize intraoperative bleeding at each level of severity and help avoid the need for transfusion of blood products.…”

“…The SG scale has been previously described based on an in vitro model of surface bleeding severity. [31] The current study was executed to validate the use of the SG scale in a clinical setting to support employment of the scale in large multicenter randomized trials [33] as well as to provide an initial evaluation for the safety and e cacy of a local hemostat, HEMOBLAST Bellows (HB).…”

Application techniques of a novel hemostat in cardiac operations: HEMOBLAST

“…Powder‐based hemostatic agents offer the advantage of the ease of use and can cover broad surgical fields or small areas without the need for additional applicators or pressurized gases. These agents are easy to dispense to the surgeon in a matter of seconds and do not require refrigeration or mixing . From a clinical application prospective, we have used the product in over 60 open cardiothoracic and vascular procedures since late 2018.…”

“…These agents are easy to dispense to the surgeon in a matter of seconds and do not require refrigeration or mixing. 6 From a clinical application prospective, we have used the product in over 60 open cardiothoracic and vascular procedures since late 2018. Improvements in the field of hemostasis have been noted in the majority of these high-risk patients prone to bleeding (ie, cardiac surgery revisions, LVAD patients, patients on platelet inhibitors, etc.…”

“…The bellows, (Figure A and B) which contains the hemostat, includes 1.65 g of powder. This device has been evaluated in a recent prospective, randomized, controlled trial, and received the U.S. Food and Drug Administration approval for use in minimal, mild, and moderate bleeding …”