Department of Orthopaedic Surgery, the University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Department of Spine and Orthopedic Surgery, Japanese Red Cross Medical Center, 4-1-22 Hiroo, Shibuya-ku, Tokyo, 150-8935, Japan.
BMC Musculoskelet Disord. 2023 Apr 13;24(1):289. doi: 10.1186/s12891-023-06408-8.
A prospective cohort study.
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.
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 microendoscopy-assistance 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.
Intraoperative TGM was used in 1934 cases (35.0%), among which 714 were unplanned (12.9%). Predictors of unplanned TGM use were female gender (adjusted odds ratio [OR]: 1.21, 95% confidence interval [CI]: 1.02-1.43, p = 0.03), ASA grade ≥ 2 (OR: 1.34, 95% CI: 1.04-1.72, p = 0.02), cervical spine (OR: 1.55, 95% CI: 1.24-1.94, p < 0.001), tumor (OR: 2.02, 95% CI: 1.34-3.03, p < 0.001), posterior approach (OR: 1.66, 95% CI: 1.26-2.18, p < 0.001), durotomy (OR: 1.65, 95% CI: 1.24-2.20, p < 0.001), instrumentation (OR: 1.30, 1.03-1.63, p = 0.02), osteotomy (OR: 5.00, 2.76-9.05, p < 0.001), and microendoscopy (OR: 2.24, 1.84-2.73, p < 0.001).
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. While routine usage of TGM in these cases will require further justification, these novel findings are valuable for implementing preoperative precautions and optimizing resource allocation.
前瞻性队列研究。
凝血酶明胶基质（TGM）是一种快速有效的止血剂，但它存在一些局限性，包括成本和准备时间。本研究旨在调查 TGM 的使用现状，并确定其使用的预测因素，以确保其合理使用和优化资源配置。
在一年内在一个多中心研究组中接受脊柱手术的 5520 名患者被纳入研究。调查了人口统计学因素和手术因素，包括手术的脊柱节段、急诊手术、再次手术、手术入路、硬脊膜切开术、器械固定、椎间融合、截骨术和显微镜辅助。还检查了 TGM 的使用情况，以及是否因无法控制的出血而常规或非计划性使用。使用多变量逻辑回归分析来确定非计划性使用 TGM 的预测因素。
术中使用了 1934 例（35.0%）TGM，其中 714 例为非计划性使用（12.9%）。非计划性使用 TGM 的预测因素包括女性（调整后的优势比[OR]：1.21，95%置信区间[CI]：1.02-1.43，p=0.03）、ASA 分级≥2 级（OR：1.34，95% CI：1.04-1.72，p=0.02）、颈椎（OR：1.55，95% CI：1.24-1.94，p<0.001）、肿瘤（OR：2.02，95% CI：1.34-3.03，p<0.001）、后路（OR：1.66，95% CI：1.26-2.18，p<0.001）、硬脊膜切开术（OR：1.65，95% CI：1.24-2.20，p<0.001）、器械固定（OR：1.30，1.03-1.63，p=0.02）、截骨术（OR：5.00，2.76-9.05，p<0.001）和显微镜辅助（OR：2.24，1.84-2.73，p<0.001）。
许多非计划性使用 TGM 的预测因素以前曾被报道为术中大量出血和输血的危险因素。然而，其他新发现的因素可能是难以控制的出血的预测因素。虽然在这些情况下常规使用 TGM 需要进一步证明，但这些新发现对于实施术前预防措施和优化资源配置是有价值的。
