Evidence map›Paper›PMID 36959672›Full record

ArticleTrials2023

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

Birgit Coucke, Anaïs Van Hoylandt, Johannes van Loon, Frank Van Calenbergh, Laura Van Gerven, Tom Theys

Registry-linked trialFull text readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03812120 (L-PRF in Cranial Surgery), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03812120 naunknown statusnot on this map

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

TypeinterventionalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2018 to 2023Enrolled350ConditionsCranial Sutures, ClosureArmsDural closure with L-PRF, Dural closure with classical fibrin sealants
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. TachoSilNeurosurgical review · 2026
    Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Birgit CouckeResearch Group Experimental Neurosurgery and Neuroanatomy and the Leuven Brain Institute, Department of Neurosciences, KU Leuven, Leuven, Belgium. birgit.coucke@kuleuven.be.ORCID http://orcid.org/0000-0003-0285-6665
Anaïs Van HoylandtDepartment of Neurosurgery, University Hospitals Leuven, Leuven, Belgium.
Johannes van LoonResearch Group Experimental Neurosurgery and Neuroanatomy and the Leuven Brain Institute, Department of Neurosciences, KU Leuven, Leuven, Belgium.
Frank Van CalenberghResearch Group Experimental Neurosurgery and Neuroanatomy and the Leuven Brain Institute, Department of Neurosciences, KU Leuven, Leuven, Belgium.
Laura Van GervenAllergy and Clinical Immunology Research Group, Department of Microbiology, Immunology & Transplantation, KU Leuven, Leuven, Belgium.
Tom TheysResearch Group Experimental Neurosurgery and Neuroanatomy and the Leuven Brain Institute, Department of Neurosciences, KU Leuven, Leuven, Belgium.

Funding

Fonds Wetenschappelijk Onderzoek T003018N
6 · The paper itself

Abstract

backgroundCSF 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. METHODS/

designThis 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. DISCUSSION: With this trial, we will evaluate the safety and efficiency of L-PRF compared to commercially available fibrin sealants.

trial registrationClinicalTrials.gov NCT03812120. Registered on 22 January 2019.

Indexed as

Platelet-Rich FibrinCerebrospinal Fluid LeakEquivalence Trials as TopicFibrin Tissue AdhesiveHumansPostoperative ComplicationsProspective StudiesRandomized Controlled Trials as TopicFibrin Tissue AdhesiveCSF leakageDuraPreventionSealing

Identifiers

PMID36959672
PMCPMC10034240

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read26
identifiers read3
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.