Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage (EarlyVPS)
Primary Purpose
Subarachnoid Hemorrhage, Ventriculo-Peritoneal Shunt Infection, Hydrocephalus
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS)
Sponsored by
About this trial
This is an interventional treatment trial for Subarachnoid Hemorrhage focused on measuring High grade subarachnoid hemorrhage, External ventricular drainage, Ventricular-peritoneal shunt
Eligibility Criteria
Inclusion Criteria:
- patients with SAH and World Federation of Neurosurgeon (WFNS) Grade 4 or 5 and
- patient who underwent ventriculostomy (EVD insertion) within 24 hours of SAH onset.
Exclusion Criteria:
- patients with Glasgow Coma Scale of (GCS) 3 and fixed non-reactive pupils,
- patients in whom EVD was inserted in the other hospital,
- patients were successfully weaned from EVD with 7-10 days of EVD insertion
- patients who died during hospitalization.
Sites / Locations
- Ghaem Hospital, Mashhad University of Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Early VPS
Arm Description
Outcomes
Primary Outcome Measures
rate of ventriculo-peritoneal malfunction
VPS is defined malfunction when signs of hydrocephalus are seen in imaging (CTS or MRI)/clinical findings
rate of ventricle-peritoneal infection
Secondary Outcome Measures
RBC / protein level in CSF association with VPS malfunction
Full Information
NCT ID
NCT04567277
First Posted
September 23, 2020
Last Updated
March 17, 2022
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04567277
Brief Title
Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage
Acronym
EarlyVPS
Official Title
Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
February 2021 (Actual)
Study Completion Date
March 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Acute hydrocephalus is a common complication following subarachnoid hemorrhage (SAH). Early and emergency insertion of external ventricular drain (EVD) is standard treatment of acute post-SAH hydrocephalus. According to the high risk of infection associated with EVD, the study evaluates the outcome of early EVD conversion to ventriculoperitoneal shunt (VPS) in poor-grade SAH patients.
Detailed Description
This study was performed on patients diagnosed with high grade SAH (WFNS 4-5) who undergo EVD within 24 hours of their admission. The conversion of EVD to VPS is performed within 7-10 days of EVD insertion, defined as early VPS group. The ventricular catheter is inserted in lateral ventricle using the same burr hole of EVD or the contralateral Kocher's point. All ruptured aneurysms could be closed by endovascular techniques or surgery.
The goal is to discontinuing EVD or its conversion to VPS within 7 to 10 days of insertion. At day 5-7 of EVD insertion, the EVD level is elevated from 15 cmH2O to 25 centimeter of water (cmH2O) gradually. The patients is evaluated during the 48 hours for cerebrospinal fluid (CSF) volume discharge, neurological consciousness, and hydrocephalus within brain CT scan acquired at the end of 48 hours of observation. If the daily CSF fluid discharge will be greater than 100 ml, brain CT scan shows evidence of HCP, there is any CSF leak from around the catheter, or the patient experiences GCS drop for 2 points or more, EVD is converted to VPS.
EVD conversion to VPS is postponed if there is any evidence of CSF infection within the last CSF analysis obtained 48 hours before VPS placement, patient experiences fever (>38.5° C) without any other source, or there is any evidence of severe vasospasm in transcranial Doppler (TCD) imaging or brain CT angiography. Otherwise, The EVD is discontinued.
For all patients, a brain CT scan is taken to evaluate the location of shunt 24 hours after VPS placement. Forty-eight hours after VPS placement, lumbar puncture (LP) is performed to collect CSF for ruling out the possibility of shunt infection or ventriculitis. Shunt malfunction (approved by imaging or signs of HCP) is reported if it occurred within 3 months of VPS placement.
When VPS malfunction is diagnosed it is revised. CSF infection is considered if there is a positive culture or ratio of CSF white blood cell count (WBC)/ red blood cell count (RBC) to blood WBC/RBC was more than 3. All patients is evaluated for clinical condition using modified Rankin scale (mRs) at discharge and 6 months later.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Ventriculo-Peritoneal Shunt Infection, Hydrocephalus
Keywords
High grade subarachnoid hemorrhage, External ventricular drainage, Ventricular-peritoneal shunt
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study has a single group including patients with high grade subarachnoid hemorrhage (WFNS 3-4) for whom EVD was inserted. EVD was tried converted into VPS within 7-10 days of insertion.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early VPS
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS)
Intervention Description
EVD in high grade SAH patients were converted into VPS with 7-10 days of EVD insertion
Primary Outcome Measure Information:
Title
rate of ventriculo-peritoneal malfunction
Description
VPS is defined malfunction when signs of hydrocephalus are seen in imaging (CTS or MRI)/clinical findings
Time Frame
3 months
Title
rate of ventricle-peritoneal infection
Time Frame
3 months
Secondary Outcome Measure Information:
Title
RBC / protein level in CSF association with VPS malfunction
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with SAH and World Federation of Neurosurgeon (WFNS) Grade 4 or 5 and
patient who underwent ventriculostomy (EVD insertion) within 24 hours of SAH onset.
Exclusion Criteria:
patients with Glasgow Coma Scale of (GCS) 3 and fixed non-reactive pupils,
patients in whom EVD was inserted in the other hospital,
patients were successfully weaned from EVD with 7-10 days of EVD insertion
patients who died during hospitalization.
Facility Information:
Facility Name
Ghaem Hospital, Mashhad University of Medical Sciences
City
Mashhad
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage
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