Leukocyte- and platelet-rich fibrin in cranial surgery: study protocol for a prospective, parallel-group, single-blinded randomized controlled non-inferiority trial {1}

• Published in: Current controlled trials in cardiovascular medicine 2023-03, Vol.24 (1), p.219-219, Article 219
• Main Authors: Coucke, Birgit, Van Hoylandt, Anaïs, van Loon, Johannes, Van Calenbergh, Frank, Van Gerven, Laura, Theys, Tom
• Format: Article
• Language: English
• Subjects: Blood platelets; Brain surgery; Cerebrospinal Fluid Leak - etiology; Clinical trials; CSF leakage; Dura; Endoscopy; Fibrin; Fibrin Tissue Adhesive - adverse effects; Humans; Informed consent; Medical equipment; Nervous system; Neurosurgery; Patients; Platelet-Rich Fibrin; Postoperative Complications - etiology; Prevention; Prospective Studies; Quality control; Quality of life; Questionnaires; R&D; Randomized Controlled Trials as Topic; Research & development; Sealing; Sealing compounds; Study Protocol; Surgery; Testing
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-023-07252-w

CSF leakage is a major complication after cranial surgery, thus, adequate dural closure must be performed. Commercially available fibrin sealants are currently considered the gold standard for dural closure, but problems have been reported regarding safety, efficacy, and costs. This trial aims to investigate autologous leukocyte- and platelet-rich fibrin (L-PRF) as an alternative to commercially available fibrin sealants. This single-blinded, prospective randomized controlled interventional trial aims to demonstrate the non-inferiority of L-PRF compared to commercially available fibrin sealants for dural closure. This trial will include patients undergoing cranial neurosurgery (supratentorial and infratentorial) with intentional opening of the dura. Patients are randomized in a 1:1 fashion comparing L-PRF to commercially available fibrin sealants. The primary endpoint is postoperative CSF leakage within 12 weeks after surgery. Secondary endpoints are complications such as bleeding or wound infections. Additionally, a cost-effectiveness analysis is performed. With this trial, we will evaluate the safety and efficiency of L-PRF compared to commercially available fibrin sealants. ClinicalTrials.gov NCT03812120. Registered on 22 January 2019.