1Department of Neurosciences, Research Group Experimental Neurosurgery and Neuroanatomy and the Leuven Brain Institute, KU Leuven.
2Department of Microbiology, Immunology, & Transplantation, Allergy and Clinical Immunology Research Group, KU Leuven.
J Neurosurg. 2024 Feb 23;141(2):500-508. doi: 10.3171/2023.12.JNS232125. Print 2024 Aug 1.
CSF leakage is a major complication after cranial surgery, and although fibrin sealants are widely used for reinforcing dural closure, concerns exist regarding their safety, efficacy, and cost. Leukocyte- and platelet-rich fibrin (L-PRF), an autologous platelet concentrate, is readily available and inexpensive, making it a cost-effective alternative for commercially available fibrin sealants. This study aimed to demonstrate the noninferiority of L-PRF compared with commercially available fibrin sealants in preventing postoperative CSF leakage in supra- and infratentorial cranial surgery, with secondary outcomes focused on CSF leakage risk factors and adverse events.
In a single-blinded, prospective, randomized controlled interventional trial conducted at a neurosurgery department of a tertiary care center (UZ Leuven, Belgium), patients undergoing elective cranial neurosurgery were randomly assigned to receive either L-PRF (active treatment) or commercially available fibrin sealants (control) for dural closure in a 1:1 ratio.
Among 350 included patients, 328 were analyzed for the primary endpoint (44.5% male, mean age 52.3 ± 15.1 years). Six patients (5 in the control group, 1 in the L-PRF group) presented with CSF leakage requiring any intervention (relative risk [RR] 0.20, one-sided 95% CI -∞ to 1.02, p = 0.11), confirming noninferiority. Of these 6 patients, 1 (in the control group) presented with CSF leakage requiring revision surgery. No risk factors for reconstruction failure in combination with L-PRF were identified. RRs for adverse events such as infection (0.72, 95% CI -∞ to 1.96) and meningitis (0.36, 95% CI -∞ to 1.25) favored L-PRF treatment, although L-PRF treatment showed slightly more bleeding events (1.44, 95% CI -∞ to 4.66).
Dural reinforcement with L-PRF proved noninferior to commercially available fibrin sealants, with no safety issues. Introducing L-PRF to standard clinical practice could result in important cost savings due to accessibility and lower cost. Clinical trial registration no.: NCT03812120 (ClinicalTrials.gov).
脑脊液漏是颅脑手术后的主要并发症，尽管纤维蛋白密封剂被广泛用于加强硬脑膜闭合，但人们对其安全性、有效性和成本仍存在担忧。富含白细胞和血小板的纤维蛋白（L-PRF）是一种自体血小板浓缩物，易于获得且价格低廉，因此是市售纤维蛋白密封剂的一种具有成本效益的替代品。本研究旨在证明 L-PRF 与市售纤维蛋白密封剂在预防幕上和幕下颅脑手术后脑脊液漏方面的非劣效性，次要结局重点关注脑脊液漏的危险因素和不良事件。
在比利时三级护理中心的神经外科部门进行的一项单盲、前瞻性、随机对照干预试验中，将择期行颅脑神经外科手术的患者以 1:1 的比例随机分为接受 L-PRF（活性治疗）或市售纤维蛋白密封剂（对照）进行硬脑膜闭合。
在纳入的 350 例患者中，328 例患者分析了主要终点（44.5%为男性，平均年龄 52.3±15.1 岁）。有 6 例患者（对照组 5 例，L-PRF 组 1 例）出现需要任何干预的脑脊液漏（相对风险 [RR]0.20，单侧 95%CI-∞至 1.02，p=0.11），证实了非劣效性。在这 6 例患者中，有 1 例（对照组）出现需要翻修手术的脑脊液漏。未发现与 L-PRF 联合使用的重建失败的危险因素。感染（0.72，95%CI-∞至 1.96）和脑膜炎（0.36，95%CI-∞至 1.25）等不良事件的 RR 有利于 L-PRF 治疗，尽管 L-PRF 治疗的出血事件略多（1.44，95%CI-∞至 4.66）。
L-PRF 强化硬脑膜与市售纤维蛋白密封剂相比非劣效，且无安全性问题。由于易于获得和成本较低，将 L-PRF 引入标准临床实践可能会带来重要的成本节约。临床试验注册号：NCT03812120（ClinicalTrials.gov）。
