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

NCT04567277 | Completed DMC

• 1 other identifier: T5097
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage; Ventriculo-Peritoneal Shunt Infection; Hydrocephalus

Keywords

High grade subarachnoid hemorrhage; External ventricular drainage; Ventricular-peritoneal shunt

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• RBC / protein level in CSF association with VPS malfunction

  3 months

Study Arms (1)

Early VPS

EXPERIMENTAL

Procedure: External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS)

Interventions

External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS) PROCEDURE

EVD in high grade SAH patients were converted into VPS with 7-10 days of EVD insertion

Early VPS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Ghaem Hospital, Mashhad University of Medical Sciences

Mashhad, Iran

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Hydrocephalus

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgical Department

Model Details: 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.

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 28, 2020
• Study Start: January 1, 2017
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

IR (1)