Status:
TERMINATED
Comparison of EVD Catheter Diameter on Occlusion and Replacement
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Occlusion
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
A randomized trial comparing small versus large catheters in terms of occlusion and need for replacement to confirm differential occlusion risk based on catheter size. This study will be done to deter...
Detailed Description
Ventriculostomy is a common neurosurgical procedure. A Nationwide Inpatient Sample (NIS) database study demonstrated a significant increase in ventriculostomy utilization from 1988-2010, with over 35,...
Eligibility Criteria
Inclusion
- Adult patients (18-85 years old) with a Glasgow Coma Scale (GCS) score of 7 or higher requiring frontal EVD placement.
- Diagnoses: spontaneous subarachnoid hemorrhage, intraventricular hemorrhage, intraparenchymal or cerebellar hemorrhage due to aneurysm, arteriovenous malformation, arteriovenous fistula, hypertension, or idiopathic etiology.
- Also included are patients for whom the attending neurosurgeon decides that frontal EVD placement is indicated for patient treatment with planned cerebrospinal fluid (CSF) drainage for 72 hours or more.
Exclusion
- GCS of 6 or less
- Hunt and Hess subarachnoid hemorrhage grade of 5.
- Age 86 or greater, or age 17 or less.
- Patient cannot consent and next of kin cannot consent prior to procedure.
- Diagnosis of traumatic brain injury, as the EVD is often clamped for extended periods of time.
- Patients anticoagulated prior to admission with warfarin, Effient, Plavix, therapeutic heparin infusion, therapeutic subcutaneous lovenox, therapeutic subcutaneous arixtra, or other therapeutic anticoagulant or antiplatelet agent (ASA not included).
- Plan for EVD placement through non-frontal burr hole.
Key Trial Info
Start Date :
June 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03248739
Start Date
June 12 2017
End Date
November 4 2022
Last Update
October 25 2023
Active Locations (1)
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1
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27104