L-PRF in Cranial Surgery

L-PRF in Cranial Surgery: a Prospective, Randomized Trial

The investigators want to demonstrate in a prospective, randomized trial including 350 patients undergoing cranial surgery that the use of L-PRF is non-inferior to classical fibrin sealants.

The investigators want to demonstrate in a prospective, randomized trial including 350 patients undergoing cranial surgery that the use of L-PRF is non-inferior to classical fibrin sealants.

Approximately 350 patients undergoing cranial surgery will be enrolled in this randomized, controlled, single-blinded monocenter study to evaluate the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair (= primary objective).

The investigators will also evaluate if the use of L-PRF obviates the need for the use of other autologous grafts (e.g. muscle/fat), commercial collagen-based products (e.g. Tachosil) or articifial dura (=secondary objective).

Inclusion Criteria:

• Patients undergoing cranial neurosurgery whereby the dura is intentionally opened (supratentorial and infratentorial approach)
• Age ≥ 18 years
• Written informed consent
• Willing to comply with the study schedule

Exclusion Criteria:

• Participation in another clinical trial with study drugs or devices
• Pregnancy