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

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ClinicalTrials.gov Identifier: NCT04567277
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Humain Baharvahdat, Mashhad University of Medical Sciences

Study Description
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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) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage
Actual Study Start Date : January 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

Arms and Interventions
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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
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Primary Outcome Measures :
  1. rate of ventriculo-peritoneal malfunction [ Time Frame: 3 months ]
    VPS is defined malfunction when signs of hydrocephalus are seen in imaging (CTS or MRI)/clinical findings

  2. rate of ventricle-peritoneal infection [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. RBC / protein level in CSF association with VPS malfunction [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04567277


Contacts
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Contact: Humain Baharvahdat, MD 98-9151100400 humainbv@yahoo.fr

Locations
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Iran, Islamic Republic of
Ghaem Hospital, Mashhad University of Medical Sciences Recruiting
Mashhad, Iran, Islamic Republic of
Contact: Humain Baharvahdat, MD    +98-915-110-0400    humainbv@yahoo.fr   
Sponsors and Collaborators
Mashhad University of Medical Sciences
More Information
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Responsible Party: Humain Baharvahdat, Neurosurgical Department, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04567277    
Other Study ID Numbers: T5097
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Humain Baharvahdat, Mashhad University of Medical Sciences:
High grade subarachnoid hemorrhage
External ventricular drainage
Ventricular-peritoneal shunt
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hydrocephalus
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases