Clinical trial NCT02891070: Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery
Official title: A Randomised Controlled Study to Evaluate the Efficacy and Safety of Fibrin Sealant, Vapour Heated, Solvent/Detergent Treated FS VH S/D 500 S-apr (Tisseel) Compared to DuraSeal Dural Sealant as an Adjunct to Sutured Dural Repair in Cranial Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebrospinal Fluid Leak
Keywords: Cranial Surgery
Cerebrospinal Fluid Leak
Tisseel
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2016-09-07
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for use as an adjunct to sutured dural repair in cranial surgery.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing craniotomy/craniectomy for pathological processes in the PF or ST region
2. Patients must be willing and able to participate in the study and provide written IC before any protocol specific assessment is performed
3. Patients must be willing to receive peri-operative antibiotic prophylaxis
4. Female patients of childbearing potential must present with a negative serum pregnancy test, and must agree to employ adequate birth control measures \[restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products\] for the duration of their participation in the study
5. Patients are willing and able to comply with the requirements of the protocol

Exclusion Criteria:

1. Patients with a dural lesion from a recent surgery that still has the potential for CSF leakage
2. Patients who had undergone chemotherapy treatment, excluding hormonal therapy, within 3 weeks prior to the planned procedure, or with chemotherapy scheduled within 7 days following surgery
3. Patients with radiation therapy to the surgical site or standard fractionated radiation therapy scheduled within 7 days following surgery
4. Patients with a previous craniotomy/craniectomy within 6 months prior to the study surgery
5. Use of corticosteroids on a chronic basis (defined as daily use of corticosteroids for ≥8 weeks) for purposes other than decreasing the symptoms of systemic chemotherapy (unless if those steroids were discontinued 4 weeks prior to the planned surgery)
6. Patients with a known hypersensitivity to the components of the IP or control (human fibrinogen, synthetic aprotinin, human albumin, human FXIII, tri sodium citrate, histidine, niacinamide, polysorbate 80, human thrombin, polyethylene glycol \[PEG\], trilysine amine)
7. Patients with a known hypersensitivity to US Federal Drug \& Cosmetic Blue #1 dye
8. Evidence of an infection indicated by any one of the following: clinical examination supporting the diagnosis of infection, fever (temperature \>100.7°F or 38.2°C), positive urine culture, positive blood culture, positive chest X ray consistent with pulmonary infection, or infection along the planned surgical path. A white blood cell (WBC) count of \<20000 cells/µL is permitted if the patient is being treated with steroids in the absence of all other infection parameters
9. Female patients of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period
10. Female patients who are nursing
11. Patients with exposure to another investigational drug or device clinical trial within 30 days prior to enrolment or anticipated in the 60-day Follow-up period
12. Patients with severely altered renal function as confirmed by local laboratory reference ranges for serum creatinine and/or hepatic function (alanine aminotransferase \[ALT\], aspartate aminotransferase \>3 × upper limit of normal \[ULN\])
13. Patients who currently have or have had a compromised immune system (such as Acquired Immune Deficiency Syndrome \[AIDS\]) or autoimmune disease, or were on chronic immunosuppressant agents
14. Patients with uncontrolled diabetes as evidenced by the institution's standard of care (glycated haemoglobin \[HbA1c\] \>7%, blood glucose, etc.)
15. Patients with traumatic injuries to the head
16. Patients with dural injury during craniotomy/craniectomy that cannot be eliminated by widening the craniotomy/craniectomy to recreate the native dural cuff
17. Patients requiring surgical approaches that would not allow sutured dural closure such as trans-sphenoidal or translabyrinthine/-petrosal/-mastoid. Superficial penetration of mastoid air cells is allowed
18. Patients with hydrocephalus, except occlusive hydrocephalus caused by PF pathology or incompletely open cerebrospinal fluid pathways, to be treated during surgical procedure
19. Existing CSF (ventricular, etc.) drains, Cushing/Dandy cannulation, or Burr holes which damage the dura
20. Patients with confined bony structures where nerves are present and neural compression may result due to swelling

Primary outcomes:
measure: Number of Participants With No CSF Leak During and After Surgery
timeFrame: Day 0 (Intra-operative) to Day 30 (+/-3 days) post-operative
Secondary outcomes:
measure: Number of Participants With no Intra-operative CSF Leaks Following Final Valsalva Maneuver
timeFrame: Day 0 (Intra-operative)
measure: Number of Participants With CSF Leaks Within 30 (+3) Days Post-operatively
timeFrame: Day 0 (Intra-operative) to Day 30 (+/-3 days) post-operative
measure: Duration in Surgery (Minutes)
timeFrame: Day 0 (intra-operatively)
measure: Time From Dural Closure (Application of IP) Until End of Surgery
timeFrame: Day 0 (Intra-operatively)
measure: Length of Stay in Hospital (Days).
timeFrame: Day 0 to Day 60 (Study Completion)
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Temple University School of Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Neurological Institute
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia School of Medicine
state: Virginia
city: Brno
country: Czechia
facility: University Hospital Brno
city: Brno
country: Czechia
facility: St. Anne's University Hospital Brno
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Praha 5 - Motol
country: Czechia
facility: University Hospital Motol
city: Praha 5
country: Czechia
facility: Hospital Na Homolce
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Munich
country: Germany
facility: Hospital Bogenhausen Municipal Hospital
city: Rostock
country: Germany
facility: University Hospital Rostock
city: Badalona
country: Spain
facility: University Hospital Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
city: Madrid
country: Spain
facility: University Hospital Foundation Jimenez Diaz
city: Madrid
country: Spain
facility: University Hospital 12 de Octubre
city: Palma de Mallorca
country: Spain
facility: University Hospital Son Espases
city: Valencia
country: Spain
facility: University General Hospital of Valencia
Study officials:
affiliation: Baxter Healthcare
name: Qing Li, MD, PhD
role: STUDY_DIRECTOR
References: