Intra-operative CSF leak MedDRA version: 19.0 Level: LLT Classification code 10024091 Term: Leakage of cerebrospinal fluid System Organ Class: 100000004852
Conditions
Sponsors
Baxter Healthcare Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients =18 years of age 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 INTRA-OPERATIVE 1. Patients with surgical wound classification Class I 2. The cuff of native dura along the craniotomy edge on each side is adequate, based on surgeon's judgment, to facilitate suturing and to allow for sufficient surface area for adherence of the IP 3. Patient’s CSF leak was present intra-operatively following completion of primary dural closure (with or without non-autologous duraplasty or autologous tissue); either spontaneously or upon Valsalva manoeuver (25 cm H2O for up to 5 - 10 seconds) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 309 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 167
Exclusion criteria
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 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 INTRA-OPERATIVE 1. Patient has a gap between durotomy edges of >2 mm after primary dural closure in the judgment of the inves
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of FS VH S/D 500 s-apr compared to DuraSeal Dural Sealant as an adjunct to sutured dural closure.;Secondary Objective: To evaluate the safety of FS VH S/D 500 s-apr compared to DuraSeal Dural Sealant as an adjunct to sutured dural closure. ;Primary end point(s): Proportion of patients who have neither of the following: - Intra-operative CSF leakage from dural repair after up to two FS VH S/D 500 s apr/control applications during Valsalva manoeuvre (25 cm H2O for up to 5 - 10 seconds) - Post-operative CSF leakage within 30 (+3) days post-operatively ;Timepoint(s) of evaluation of this end point: intraoperative : 3 Minutes post-operative : Day 30 (+-3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: - Incidence of intra-operative CSF leakage following final Valsalva manoeuvre - Incidence of CSF leaks within 30 (+3) days post-operatively - Time in surgery (minutes) - Time from dural closure (application of investigational product) until end of surgery - Length of stay in hospital (days) Safety: - Incidence of CSF leaks within 60 (+3) days post-operatively - Incidence of adverse events (AEs) up to 60 (+3) days post-operatively - Incidence of surgical site infections (SSIs) according to the United States (US) National Healthcare Safety Network (NHSN) within 30 (+3) days post-operatively - Number of unplanned interventions within 30 (+3) days post-operatively - Abnormal laboratory values and vital signs (e.g., elevated white blood cell [WBC] count, fever [temperature >100.7°F or 38.2°C], tachycardia [pulse >100], hypotension [mean arterial pressure <60]);Timepoint(s) of evaluation of this end point: day 0 (day of surgery), day 5 (+-2) , day 30 (+-3), day 60 (+-3) | — |
Countries
Czech Republic, Germany, Poland, Spain, United States
Contacts
Public ContactAriane Liebchen
Baxter Healthcare Corporation
Outcome results
None listed