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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

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.

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) Compared to DuraSeal Dural Sealant as an Adjunct to Sutured Dural Repair in Cranial Surgery.

Keywords

Cerebrospinal Fluid Leak Cranial Surgery Tisseel Fibrin Tissue Adhesive

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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

Locations

  • Houston Methodist Neurological Institute accepting new patients
    Houston, Texas, 77030, United States
  • Southern Illinois University School of Medicine not yet accepting patients
    Springfield, Illinois, 62711, United States
  • The Ohio State University accepting new patients
    Columbus, Ohio, 43201, United States
  • University of Pittsburgh Medical Center accepting new patients
    Pittsburgh, Pennsylvania, 15213, United States
  • University of Virginia School of Medicine accepting new patients
    Charlottesville, Virginia, 22903, United States
  • Temple University School of Medicine accepting new patients
    Philadelphia, Pennsylvania, 19140, United States
  • Baystate Medical Center accepting new patients
    Springfield, Massachusetts, 01199, United States
  • Brigham and Women's Hospital not yet accepting patients
    Boston, Massachusetts, 02130, United States
  • University Hospital Leipzig accepting new patients
    Leipzig, 04103, Germany
  • Hospital Bogenhausen Municipal Hospital accepting new patients
    Munich, 81925, Germany
  • University Hospital Rostock accepting new patients
    Rostock, 18057, Germany
  • University Hospital Germans Trias I Pujol not yet accepting patients
    Badalona, 08916, Spain
  • Hospital Clinic I Provincial de Barcelona accepting new patients
    Barcelona, 08036, Spain
  • University Hospital Foundation Jimenez Diaz accepting new patients
    Madrid, 28040, Spain
  • University Hospital 12 de Octubre accepting new patients
    Madrid, 28041, Spain
  • University Hospital Son Espases accepting new patients
    Palma de Mallorca, 07010, Spain
  • University General Hospital of Valencia accepting new patients
    Valencia, 46014, Spain
  • University Hospital Brno accepting new patients
    Brno, 62500, Czechia
  • St. Anne's University Hospital Brno accepting new patients
    Brno, 65691, Czechia
  • University Hospital Hradec Kralove accepting new patients
    Hradec Kralove, 50005, Czechia
  • University Hospital Ostrava accepting new patients
    Ostrava, 70852, Czechia
  • University Hospital Motol accepting new patients
    Praha 5 - Motol, 15006, Czechia
  • Hospital Na Homolce accepting new patients
    Praha 5, 15030, Czechia

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Baxter Healthcare Corporation
ID
NCT02891070
Phase
Phase 3
Study Type
Interventional
Last Updated
May 1, 2017
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