L-PRF in Cranial Surgery: a Prospective, Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Success rate
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants stay masked during the trial, care provider and investigators are unblinded at the surgical procedure and from thereon.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Participation in another clinical trial with study drugs or devices
- •Pregnancy
研究组 & 干预措施
Classical Treatment
In this arm, dural closure will be performed with the classical fibrine sealants.
干预措施: Dural closure with classical fibrin sealants (Procedure)
L-PRF
In this arm, dural closure will be performed with the autologous L-PRF
干预措施: Dural closure with L-PRF (Procedure)
结局指标
主要结局
Success rate
时间窗: 4 years
The success rate is considered a thigh closure of the dura in both groups, which means no CSF leakage. This success rate was estimated at 95% in both techniques.
次要结局
- Cost effectiveness evaluation(4 years)
- Complications(4 years)
研究者
Tom Theys
Professor, Dr
Universitaire Ziekenhuizen KU Leuven