Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery

Completed · Phase 3

Conditions studied: Cerebrospinal Fluid Leak

In brief

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.

Key facts

Study ID

NCT02891070

Run by

Baxter Healthcare Corporation

People needed

224

Starts

2016-10-11

Expected to finish

2018-08-22

Last updated by the study team

2019-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing craniotomy/craniectomy for pathological processes in the PF or ST region
• Patients must be willing and able to participate in the study and provide written IC before any protocol specific assessment is performed
• Patients must be willing to receive peri-operative antibiotic prophylaxis
• 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
• Patients are willing and able to comply with the requirements of the protocol

You may not qualify if…

• Patients with a dural lesion from a recent surgery that still has the potential for CSF leakage
• 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
• Patients with radiation therapy to the surgical site or standard fractionated radiation therapy scheduled within 7 days following surgery
• Patients with a previous craniotomy/craniectomy within 6 months prior to the study surgery
• 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)
• 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)
• Patients with a known hypersensitivity to US Federal Drug \& Cosmetic Blue #1 dye
• 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
• Female patients of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period
• Female patients who are nursing
• 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
• 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])
• 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
• Patients with uncontrolled diabetes as evidenced by the institution's standard of care (glycated haemoglobin [HbA1c] >7%, blood glucose, etc.)
• Patients with traumatic injuries to the head
• Patients with dural injury during craniotomy/craniectomy that cannot be eliminated by widening the craniotomy/craniectomy to recreate the native dural cuff
• 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
• Patients with hydrocephalus, except occlusive hydrocephalus caused by PF pathology or incompletely open cerebrospinal fluid pathways, to be treated during surgical procedure
• Existing CSF (ventricular, etc.) drains, Cushing/Dandy cannulation, or Burr holes which damage the dura
• Patients with confined bony structures where nerves are present and neural compression may result due to swelling

Where it is running

• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Temple University School of Medicine — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Houston Methodist Neurological Institute — Houston, Texas, United States
• University of Virginia School of Medicine — Charlottesville, Virginia, United States
• University Hospital Brno — Brno, Czechia
• St. Anne's University Hospital Brno — Brno, Czechia
• University Hospital Hradec Kralove — Hradec Králové, Czechia
• University Hospital Ostrava — Ostrava, Czechia
• Hospital Na Homolce — Prague, Czechia
• University Hospital Motol — Praha 5 - Motol, Czechia
• University Hospital Leipzig — Leipzig, Germany
• Hospital Bogenhausen Municipal Hospital — Munich, Germany
• University Hospital Rostock — Rostock, Germany
• University Hospital Germans Trias I Pujol — Badalona, Spain
• Hospital Clinic I Provincial de Barcelona — Barcelona, Spain
• University Hospital Foundation Jimenez Diaz — Madrid, Spain
• University Hospital 12 de Octubre — Madrid, Spain
• University Hospital Son Espases — Palma de Mallorca, Spain
• University General Hospital of Valencia — Valencia, Spain

Full record on ClinicalTrials.gov

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