A Safety Study of the Use of Vivostat^® Patient-Derived Fibrin Sealant Containing Tranexamic Acid in Neurosurgery

Fibrin sealants are widely used in neurosurgery for sealing of the dural closure. Fibrin sealant clots may be stabilized against fibrinolysis by the addition of agents (such as tranexamic acid or aprotinin). Aprotinin is of bovine origin and may cause immunological reactions. Tranexamic acid is an effective alternative to aprotinin in fibrin sealants. Tranexamic acid has a long history of safe use when used systemically. But it is known to cause hyperexcitably when applied topically in nervous tissue.

Aim: To study the safety of Vivostat^®-derived sealant containing tranexamic acid when used in skull base procedure in neurosurgery.

Methods: Fifty adult patients (ages 23 to 72 yrs, 17 male and 33 female) undergoing neurosurgical procedures in the skull base at the Rigshospitalet, Copenhagen, and in whom fibrin glue was planned to be used, were enrolled. At the end of surgery the Vivostat^® fibrin glue was used to seal the dural closure. Observations were carried out to identify any adverse effect that could be ascribed to the use of Vivostat^® fibrin glue up to the time of the patient leaving the hospital.

Results: Thirty-nine patients had a translabyrinthine approach for vestibular schwannomas. Six patients were operated for nonacoustic neuroma diseases in the posterior fossa. One patient had a trans-sphenoidal approach for a pituitary tumor and four patients were operated for anterior fossa tumors. There were no adverse effects that could be related to the use of fibrin sealant.

Conclusion: The Vivostat^® fibrin sealant can be used in neurosurgical procedures without any safety problems.