L-PRF in Cranial Surgery

January 18, 2019 updated by: Tom Theys, Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Classical Treatment
In this arm, dural closure will be performed with the classical fibrine sealants.
Procedure: Dural closure with classical fibrin sealants
Evaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair
Active Comparator: L-PRF
In this arm, dural closure will be performed with the autologous L-PRF
Procedure: Dural closure with L-PRF
Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate
Time Frame: 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.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost effectiveness evaluation
Time Frame: 4 years
A carefull registration of the used products (L-PRF versus commercial fibrin sealants), the quantity and the actual costs of these products will be noted during the operation procedure and will be analyzed.
4 years
Complications
Time Frame: 4 years
Analysis of perioperative and postoperative complications, in particular surgical-site infection, treatment-site bleeding and CSF leakage.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Tom Theys, Prof, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 13, 2018

First Submitted That Met QC Criteria

January 18, 2019

First Posted (Actual)

January 22, 2019

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 18, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s61460

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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