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

Sponsor

Mashhad University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT04567277

Collaborator

(none)

100

Enrollment

Location

Arm

49.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Subarachnoid Hemorrhage Ventriculo-Peritoneal Shunt Infection Hydrocephalus	Procedure: External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Feb 1, 2021

Actual Study Completion Date :

Mar 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

RBC / protein level in CSF association with VPS malfunction [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghaem Hospital, Mashhad University of Medical Sciences	Mashhad		Iran, Islamic Republic of

Sponsors and Collaborators

Mashhad University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Humain Baharvahdat, Neurosurgical Department, Mashhad University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT04567277

Other Study ID Numbers:

T5097

First Posted:

Sep 28, 2020

Last Update Posted:

Mar 18, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Humain Baharvahdat, Neurosurgical Department, Mashhad University of Medical Sciences

High grade subarachnoid hemorrhage

External ventricular drainage

Ventricular-peritoneal shunt

Additional relevant MeSH terms:

Subarachnoid Hemorrhage

Hydrocephalus

Hemorrhage

Study Results

No Results Posted as of Mar 18, 2022