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

Subarachnoid Hemorrhage Clinical Trial

— EarlyVPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04567277
• Other study ID #: T5097
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: March 2021

Study information

• Verified date: March 2022
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Hydrocephalus
• Subarachnoid Hemorrhage
• Ventriculo-Peritoneal Shunt Infection

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ghaem Hospital, Mashhad University of Medical Sciences	Mashhad

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of ventriculo-peritoneal malfunction	VPS is defined malfunction when signs of hydrocephalus are seen in imaging (CTS or MRI)/clinical findings	3 months
Primary	rate of ventricle-peritoneal infection		3 months
Secondary	RBC / protein level in CSF association with VPS malfunction		3 months