Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage (EarlyVPS)

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.

Study Overview

• Status: Completed
• Conditions: Subarachnoid Hemorrhage; Hydrocephalus; Ventriculo-Peritoneal Shunt Infection
• Intervention / Treatment: Procedure: External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS)

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Mashhad, Iran, Islamic Republic of
    • Ghaem Hospital, Mashhad University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early VPS	Procedure: External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS); EVD in high grade SAH patients were converted into VPS with 7-10 days of EVD insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of ventriculo-peritoneal malfunction	VPS is defined malfunction when signs of hydrocephalus are seen in imaging (CTS or MRI)/clinical findings	3 months
rate of ventricle-peritoneal infection		3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
RBC / protein level in CSF association with VPS malfunction	3 months

Collaborators and Investigators

• Sponsor: Mashhad University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: High grade subarachnoid hemorrhage; External ventricular drainage; Ventricular-peritoneal shunt
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage; Hydrocephalus
• Other Study ID Numbers: T5097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No