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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Classical Treatment | Placebo Comparator | In this arm, dural closure will be performed with the classical fibrine sealants. |
|
| L-PRF | Active Comparator | In this arm, dural closure will be performed with the autologous L-PRF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dural closure with L-PRF | Procedure | Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success rate | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost effectiveness evaluation | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tom Theys, Prof | Contact | 003216344290 | 003216344290 | tom.theys@uzleuven.be |
| Anais Van Hoylandt, Sc | Contact | 003216342012 | 003216342012 | anais.vanhoylands@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Tom Theys, Prof | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Theys | Recruiting | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38394657 | Derived | Coucke B, De Vleeschouwer S, van Loon J, Van Calenbergh F, Van Hoylandt A, Van Gerven L, Theys T. Leukocyte- and platelet-rich fibrin in cranial surgery: a single-blinded, prospective, randomized controlled noninferiority trial. J Neurosurg. 2024 Feb 23;141(2):500-508. doi: 10.3171/2023.12.JNS232125. Print 2024 Aug 1. | |
| 36959672 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 4, 2024 | |
| Reset | Jan 17, 2025 | |
| Release | May 12, 2025 | |
| Reset | May 29, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 4, 2024 | Jan 17, 2025 | |||
| May 12, 2025 |
| ID | Term |
|---|---|
| D002559 | Cerebrospinal Fluid Rhinorrhea |
| ID | Term |
|---|---|
| D065634 | Cerebrospinal Fluid Leak |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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randomized controlled clinical trial
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Participants stay masked during the trial, care provider and investigators are unblinded at the surgical procedure and from thereon.
| Dural closure with classical fibrin sealants | Procedure | Evaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair |
|
Analysis of perioperative and postoperative complications, in particular surgical-site infection, treatment-site bleeding and CSF leakage. |
| 4 years |
| Coucke B, Van Hoylandt A, van Loon J, Van Calenbergh F, Van Gerven L, Theys T. Leukocyte- and platelet-rich fibrin in cranial surgery: study protocol for a prospective, parallel-group, single-blinded randomized controlled non-inferiority trial 1. Trials. 2023 Mar 23;24(1):219. doi: 10.1186/s13063-023-07252-w. |
| May 29, 2025 |
| D020196 | Trauma, Nervous System |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086722 | Rhinorrhea |
| D012818 | Signs and Symptoms, Respiratory |
| D014947 | Wounds and Injuries |