SPOT GRADE II: Clinical Validation of a New Method for Reproducibly Quantifying Surgical Wound Bleeding: Prospective, Multicenter, Multispecialty, Single-Arm Study

Gaizo, Daniel J. Del; Spotnitz, William D.; Hoffman, Rachel W; Hermann, M.; Sher, Linda; Spotnitz, Russell; Genyk, Yuri; Schorn, Ian J; Gillen, Daniel L.; White, Bobby L; Miller, Bruce G.; Manson, Roberto J.

doi:10.1177/1076029620936340

Cited by 10 publications

(6 citation statements)

References 37 publications

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“…The Mirza Invasiveness Index [ 15 ] has been independently validated [ 4 ] and counts a maximum of 6 possible interventions on each vertebral level. The Spot Grade, a surface bleeding severity scale has been developed as a visual method for assessing bleeding severity based on quantitative determinations of blood flow [ 16 ]. The Validated Intraoperative Bleeding Scale (Vibe Scale) is also used which ranges from 0 (no bleeding) to 4 (unidentified or inaccessible spurting or gush which is life threatening) [ 17 ].…”

Section: Resultsmentioning

confidence: 99%

Hemostats in Spine Surgery: Literature Review and Expert Panel Recommendations

et al. 2022

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Bleeding in spine surgery is a common occurrence but when bleeding is uncontrolled the consequences can be severe due to the potential for spinal cord compression and damage to the central nervous system. There are many factors that influence bleeding during spine surgery including patient factors and those related to the type of surgery and the surgical approach to bleeding. There are a range of methods that can be employed to both reduce the risk of bleeding and achieve hemostasis, one of which is the adjunct use of hemostatic agents. Hemostatic agents are available in a variety of forms and materials and with considerable variation in cost, but specific evidence to support their use in spine surgery is sparse. A literature review was conducted to identify the pre-, peri-, and postsurgical considerations around bleeding in spine surgery. The review generated a set of recommendations that were discussed and ratified by a wider expert group of spine surgeons. The results are intended to provide a practical guide to the selection of hemostats for specific bleeding situations that may be encountered in spine surgery.

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Section: Resultsmentioning

confidence: 99%

Hemostats in Spine Surgery: Literature Review and Expert Panel Recommendations

et al. 2022

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“…Each pig received 15 standardized punch bleedings, ten on the liver and ve on the spleen. Five products (two prototype patches, two positive controls and one negative control) were applied three times (two on liver, one on spleen) per pig for evaluation of hemostasis of standardized moderate bleedings (23). At relaparotomy after 1, 2, 3, 4 or 6 weeks, the sites of the former patch application were inspected for signs of tissue and foreign body responses and biopsied for histological analyses.…”

Section: Methodsmentioning

confidence: 99%

Efficacy of a novel polyoxazoline based hemostatic patch in liver and spleen surgery

Roozen

Lomme

Calon

et al. 2023

Preprint

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BACKGROUND: A new hemostatic sealant based on a N-hydroxy-succinimide polyoxazoline (NHS-POx) polymer was evaluated to determine hemostatic efficacy and long-term wound healing and adverse effects in a large animal model of parenchymal organ surgical bleeds. METHODS: Experiment 1 included 20 pigs that were treated with two NHS-POx patch prototypes (a gelatin fibrous carrier (GFC) with NHS-POx and an oxidized regenerated cellulose (ORC) with poly(lactic-co-glycolic acid)-NHS-POx:NU-POx (nucleophilically activated polyoxazoline)), a blank gelatin patch (GFC-Blank), TachoSil®, and Veriset™ to stop moderate liver and spleen punch bleedings. After various survival periods (1-6 weeks), pigs were re-operated to evaluate patch degradation and parenchymal healing. During the re-operation experiment 2 was performed; partial liver and spleen resections with severe bleeding, and hemostatic efficacy was evaluated under normal and heparinized conditions of the two previous prototypes and one additional NHS-POx patch. In the third experiment an improved NHS-POx patch (GATT-Patch; GFC-NHS-POx and added 20% as nucleophilically activated polyoxazoline; NU-POx) was compared with TachoSil®, Veriset™ and GFC-Blank on punch bleedings and partial liver and spleen resections for rapid (10 seconds) hemostatic efficacy. RESULTS: NHS-POx-based patches showed better (GFC-NHS-POx 83.1 %, ORC-PLGA-NHS-POx: NU-POx 98.3%) hemostatic efficacy compared to TachoSil® (25.0%) and GFC blank (43.3%), and comparable efficacy with Veriset™ (96.7%) on moderate standardized punch bleedings on liver and spleen. All patches demonstrated gradual degradation over 6 weeks with a reduced local inflammation rate and an improved wound healing. For severe bleedings under non-heparinized conditions, hemostasis was achieved in 100% for Veriset™, 40% for TachoSil, and 80-100% for the three NHS-POx prototypes; similar differences between patches remained for heparinized conditions. In experiment 3, GATT-Patch, Veriset™, TachoSil and GFC-Blank reached hemostasis after 10 seconds in 100%, 42.8%, 7.1% and 14.3% respectively, and at 3 minutes in 100%, 100%, 14.3% and 35.7% respectively, on all liver and spleen punctures and resections. CONCLUSIONS: NHS-POx-based patches, and particularly the GATT-Patch, are fast in achieving effective hemostatic sealing on standardized moderate and severe bleedings without apparent long term adverse events.

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“…Initial bleeding severity was then visually assessed and graded using the SPOT GRADE TM bleeding scale (0 = dry, 1 = oozing, 2 = pooling, 3 = flowing, 4 = streaming, 5 = gushing). 17,18 Unrestricted bleeding was permitted for 30 s following the arteriotomy. All blood loss was collected, measured, and recorded.…”

Section: Study Proceduresmentioning

confidence: 99%

“…We hypothesized that HB would be superior to CG for hemorrhage control of junctional wounds in a swine model of hypothermia and hemodilution. Specifically, five endpoints were examined: blood loss volumes between the treatment groups, incidence of rebleeding, SPOT GRADE TM scores, 17,18 mean arterial pressure (MAP) values, and laboratory values, including thromboelastography (TEG) and arterial blood gas (ABG) values.…”

Section: Introductionmentioning

confidence: 99%

The evaluation of Hemoblast Bellows for arterial hemorrhage control in a swine model of vascular injury

Hafer

Verga

Sulava

et al. 2023

Trauma

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Background Uncontrolled hemorrhage remains the leading cause of preventable death on the battlefield. Hemostatic agents have increased in use and have been shown to improve survival. Combat Gauze (CG) is the most-used hemostatic gauze recommended by the Committee of Tactical Combat Casualty Care. Hemoblast Bellows (HB), a product FDA-approved for intraoperative hemorrhage, contains thrombin which differentiates it from CG and other kaolin-based hemostatic agents and has not been evaluated in the pre-hospital setting. This study aimed to compare HB to CG, in a standard swine arterial hemorrhage model. Methods Dilutional coagulopathy and hypothermia were induced in anesthetized Yorkshire-cross swine. The femoral artery was isolated and a 6 mm femoral arteriotomy was made. After a 30 s free bleed, randomly assigned hemostatic agent(s) from one of the three treatment groups: HB only, CG only, and HB + CG were applied and direct pressure was held for 3 min. At 30 min, the ipsilateral lower extremity was mobilized with a series of hip movements. Primary endpoints included blood loss, rebleeding, thromboelastogram (TEG) values, SPOT GRADE(TM) values, and mean arterial pressure (MAPs), which were monitored during the 150-min observation period. Results There were no significant differences between the treatment groups for blood loss, rebleeding, lactate, TEG values, SPOT GRADE, or MAPs for all time points examined. Conclusions We found no significant differences between the treatment groups for any of the included data points. These results suggest that arterial hemorrhage control with HB alone and HB + CG is not significantly different from hemorrhage control with CG only. These findings should not deter us from a continued investigation of hemostatic agents but should stimulate our search for superior hemorrhage control agents and novel delivery mechanisms. Continued innovation with such products may overcome the product limitations that we observed during testing and may prove to be a more relevant product for the point-of-injury.

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SPOT GRADE II: Clinical Validation of a New Method for Reproducibly Quantifying Surgical Wound Bleeding: Prospective, Multicenter, Multispecialty, Single-Arm Study

Cited by 10 publications

References 37 publications

Hemostats in Spine Surgery: Literature Review and Expert Panel Recommendations

Hemostats in Spine Surgery: Literature Review and Expert Panel Recommendations

Efficacy of a novel polyoxazoline based hemostatic patch in liver and spleen surgery

The evaluation of Hemoblast Bellows for arterial hemorrhage control in a swine model of vascular injury

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