Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System
Condition: Intraventricular Hemorrhage; Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Intervention: Bactiseal TM EVD; Standard EVD Catheter
Intervention description: Standard of care implantation of external ventricular drainage catheter; Standard of care EVD system other than Bactiseal.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 434.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ventriculostomy; EVD

Summary:

      The purpose of this non-significant risk study is to establish initial baseline infection
      rates for the Codman BACTISEAL External Ventricular Drainage (B-EVD) System (Antibiotic
      impregnated catheter) and to compare relative rates of ventriculostomy-related infection
      between Subjects with BACTISEAL or conventional EVD catheters in a prospective, randomized
      open label study
    

Eligibility criteria:

        Inclusion Criteria:

          -  The Subject is 18 years or older.

          -  The Subject (family member/legal representative) has given written Informed Consent
             prior to enrollment into this trial OR, where the Subject is unable to consent and no
             relative/legal representative is available to offer consent, appropriate legal and
             ethical practices are employed and thoroughly documented according to the laws and
             policies of the respective country and institution.

          -  The Subject (family member/legal representative) is willing to participate in this
             trial for the duration of the implanted EVD system and is willing to comply with the
             protocol requirements.

        Exclusion Criteria:

          -  Within the preceding 30 days, the Subject has enrolled or participated in another
             trial utilizing an anti-microbial drug or medical device implanted in or directly
             influencing the CNS and/or spinal cord.

          -  The Subject is pregnant or lactating.

          -  The Subject has a suspected or documented allergy to the materials of the EVD system,
             including silicone, rifampin and clindamycin.

          -  The Subject has a positive CSF culture prior to EVD implant.

          -  The Subject is immunocompromised.

          -  The Subject requires more than one ventricular catheter concurrently.

          -  The Subject has had an EVD catheter within the previous 30 days.

          -  The Subject has sepsis, ventriculitis, meningitis, a skin infection/inflammation at or
             near the implantation site, an ear infection on either side, or a severe respiratory
             tract infection that, in the opinion of the Investigator, would most likely compromise
             the effectiveness of the EVD system.

          -  The Subject is known to have received systemic antibiotic therapy within a 14-day
             period preceding screening for inclusion in this trial.

          -  The Subject has an uncontrolled coagulopathy or any other known bleeding diathesis.

          -  The Subject is otherwise determined by the Investigator to be medically unsuitable for
             participation in this trial.

          -  The Subject is a prisoner.