Prospective, multicenter, randomized, controlled trial evaluating the performance of a novel combination powder vs hemostatic matrix in cardiothoracic operations

Dang, Nicholas C.; Ardehali, A.; Bruckner, Brian A.; Parrino, Patrick E.; Gillen, Daniel L.; Hoffman, Rachel W; Spotnitz, Russell; Cavoores, Stephanie; Shorn, Ian J.; Manson, Roberto J.; Spotnitz, William D.

doi:10.1111/jocs.14376

Cited by 12 publications

(14 citation statements)

References 16 publications

(20 reference statements)

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“…As a more recently introduced product, there are fewer clinical reports describing the use of Hemoblast than there are for Surgiflo. However, a small (105 subjects), multicenter, randomized clinical trial of nonemergent cardiothoracic procedures showed that Hemoblast was superior to Floseal Hemostatic Matrix for total TTH, a measure of TTH that includes the time required to prepare the device, at 3 and 5 min [49]. Hemoblast is a ready-to-use powder that does not require mixing of components, thus eliminating preparation time before application as required by Floseal, Surgiflo, and some other commercially available products [19,21,50].…”

Section: Discussionmentioning

confidence: 99%

Hemostatic efficacy of two topical adjunctive hemostats in a porcine spleen biopsy punch model of moderate bleeding

Macdonald

Zhang

Tasse

et al. 2021

J Mater Sci: Mater Med

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Topical hemostatic agents have become essential tools to aid in preventing excessive bleeding in surgical or emergency settings and to mitigate the associated risks of serious complications. In the present study, we compared the hemostatic efficacy of SURGIFLO® Hemostatic Matrix Kit with Thrombin (Surgiflo—flowable gelatin matrix plus human thrombin) to HEMOBLAST™ Bellows Hemostatic Agent (Hemoblast—a combination product consisting of collagen, chondroitin sulfate, and human thrombin). Surgiflo and Hemoblast were randomly tested in experimentally induced bleeding lesions on the spleens of four pigs. Primary endpoints included hemostatic efficacy measured by absolute time to hemostasis (TTH) within 5 min. Secondary endpoints included the number of product applications and the percent of product needed from each device to achieve hemostasis. Surgiflo demonstrated significantly higher hemostatic efficacy and lower TTH (p < 0.01) than Hemoblast. Surgiflo-treated lesion sites achieved hemostasis in 77.4% of cases following a single product application vs. 3.3% of Hemoblast-treated sites. On average, Surgiflo-treated sites required 63% less product applications than Hemoblast-treated sites (1.26 ± 0.0.51 vs. 3.37 ± 1.16). Surgiflo provided more effective and faster hemostasis than Hemoblast. Since both products contain thrombin to activate endogenous fibrinogen and accelerate clot formation, the superior hemostatic efficacy of Surgiflo in the porcine spleen punch biopsy model seems to be due to Surgiflo’s property as a malleable barrier able to adjust to defect topography and to provide an environment for platelets to adhere and aggregate. Surgiflo combines a flowable gelatin matrix and a delivery system well-suited for precise application to bleeding sites where other methods of hemostasis may be impractical or ineffective.

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Section: Discussionmentioning

confidence: 99%

Hemostatic efficacy of two topical adjunctive hemostats in a porcine spleen biopsy punch model of moderate bleeding

Macdonald

Zhang

Tasse

et al. 2021

J Mater Sci: Mater Med

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“…18 Previous authors have examined the retrospective performance of a powdered hemostatic agent 18 as well as the prospective comparative performance of hemostatic agents including powders in cardiothoracic procedures. 15,[19][20][21][22][23][24][25][26][27][28][29][30] However, to the best of our knowledge, this report presents the first direct comparison of 2 powdered hemostatic agents during cardiac surgical procedures.…”

Section: Discussionmentioning

confidence: 99%

“…In challenging surgical settings, hemostatic agents can be useful adjuncts to the armamentarium available to surgeons for the control of bleeding 8 – 12 and are known to be useful during cardiothoracic surgical operations. 13 – 15 Recently, a new powder has been added to the toolbox of available hemostatic agents. 16 This study compares a novel combination powder (CP) hemostatic agent (HEMOBLAST™ Bellows, Biom’Up France SAS, Lyon, France) 16 consisting of porcine collagen, bovine chondroitin sulfate, and human pooled plasma thrombin to an established plant derived, polysaccharide starch powder (PP) hemostatic agent (Arista ™ AH, Becton Dickinson/Bard, Warwick, RI, USA) 17 to assess the usefulness of CP.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the Safety and Efficacy of a Novel Thrombin Containing Combination Hemostatic Powder Using a Historical Control

Bruckner

Spotnitz

Suarez

et al. 2021

Clin Appl Thromb Hemost

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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.

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“…After being unpacked, thrombin is dissolved in saline and mixed with the gelatin matrix in a canister. The preparation time required may depend on the users' experience, but the whole process could take up to 3 minutes, [4,5] and in order to respond to massive intraoperative bleeding in a timely manner, TGM must be stored on-site in the operating room instead of in storage.…”

Section: Introductionmentioning

confidence: 99%

Predictors for hemostatic thrombin-gelatin matrix usage in spine surgery: A multicenter observational study

Kato

Miyahara

Matsubayashi

et al. 2022

Preprint

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Study design. A prospective cohort study. Objectives. Thrombin-gelatin matrix (TGM) is a rapid and potent hemostatic agent, but it has some limitations, including the cost and its preparation time. The purpose of this study was to investigate the current trend in the use of TGM and to identify the predictors for TGM usage in order to ensure its proper use and optimized resource allocation. Methods. A total of 5520 patients who underwent spine surgery in a multicenter study group within a year were included in the study. The demographic factors and the surgical factors including spinal levels operated, emergency surgery, reoperation, approach, durotomy, instrumented fixation, interbody fusion, osteotomy, and endoscopy were investigated. TGM usage and whether it was routine or unplanned use for uncontrolled bleeding were also checked. A multivariate logistic regression analysis was used to identify predictors for unplanned use of TGM. Results. The mean age was 63.5 years old, and males accounted for 59.9% of patients. The mean operation time was 147 minutes, median blood loss was 50mL, and interquartile range was 145mL. Intraoperative TGM was used in 1934 cases (35.0%), among which 714 were unplanned (12.9%). Predictors of unplanned TGM use were female gender, cervical spine, tumor, posterior approach, durotomy, instrumentation, osteotomy, and endoscopy. Conclusions. Many of the predictors for unplanned TGM use have been previously reported as risk factors for intraoperative massive hemorrhaging and blood transfusion. However, other newly revealed factors can be predictors of bleeding that is technically challenging to control.

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Prospective, multicenter, randomized, controlled trial evaluating the performance of a novel combination powder vs hemostatic matrix in cardiothoracic operations

Cited by 12 publications

References 16 publications

Hemostatic efficacy of two topical adjunctive hemostats in a porcine spleen biopsy punch model of moderate bleeding

Hemostatic efficacy of two topical adjunctive hemostats in a porcine spleen biopsy punch model of moderate bleeding

Evaluation of the Safety and Efficacy of a Novel Thrombin Containing Combination Hemostatic Powder Using a Historical Control

Predictors for hemostatic thrombin-gelatin matrix usage in spine surgery: A multicenter observational study

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