Assessing the Accuracy and the Impact of Standard-practice Ventricular Drainage on Intracranial Pressure Measurements Following Traumatic Brain Injury

NCT02911675 | Withdrawn DMC

• 1 other identifier: HP-00064113
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Traumatic brain injury (TBI) is a leading cause of death following injury in civilian populations and is a major cause of death and disability in combat casualties. While primary brain injury cannot be reversed, the management of severe TBI focuses on the mitigation of secondary injury mechanisms which occur as part of the downstream effects of the primary damage to the brain. Many secondary injury mechanisms are manifested clinically as elevated intracranial pressure (ICP) and cerebral perfusion pressure (CCP). This level and duration of elevated ICP is strongly associated with poor long term patient outcome. Currently, there are two invasive techniques that are used at our facility for monitoring ICP and CPP. The first method requires the placement of an intra-parenchymal fiberoptic pressure monitor (IPM), also known as a camino, into the brain tissue that measures and displays ICP continuously. The second method requires placement of an extracranial ventricular drain (EVD) which both measures ICP when it is closed or clamped and also allows for therapeutic drainage of cerebral spinal fluid (CFS) to reduce pressure within the skull when it is open. While clinical practices vary greatly across institutions, current clinical practice at our institution when using the EVD for ICP management is to allow continuous therapeutic CSF drainage and to manually close the drain for ICP assessment on an hourly basis. However, in a retrospective of study of TBI patients at our institution with simultaneous IPM and EVD placement, a spike in ICP was noted to correspond with the clamping of the EVD which often remained elevated for 15-30 minutes before returning to baseline. Due to the strong association between poor patient outcome and elevated ICP, this finding is alarming. These findings have important implications for procedures to not only treat elevated ICP, but also prevent potentially harmful intermittent elevations in ICP. Therefore, this study seeks to prospectively investigate the association between EVD clamping and elevated ICP. Specifically, this study has 2 main objectives:

1. 1.Evaluate the need for an optimized device that can simultaneously measure intracranial pressure and drain CSF without requiring potentially harmful clamping.
2. 2.Provide data in support of retaining or modifying current clinical practices regarding intermittent versus continuous monitoring during periods of therapeutic drainage of CSF.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Evaluate the need for an optimized device that can simultaneously measure intracranial pressure and drain CSF without requiring potentially harmful clamping.

  Investigators want to find a better device that can measure pressure in the head after a traumatic brain without causing an increase in pressure inside of the head.

  6 months

Secondary Outcomes (1)

• Compare clinical practices regarding intermittent versus continuous monitoring during periods of therapeutic drainage of CSF.

  6 months

Other Outcomes (1)

• Evaluate the impact of the frequency of EVD drain closure on short and long (6 month) term functional outcomes.

  6 months

Study Arms (2)

Standard of Care Group

Study Group 1: Standard EVD/IVC management with therapeutic CSF drainage as appropriate and hourly EVD/IVC ICP measurements per standard of care with simultaneous IPM/Camino ICP measurements collected.

Device: EVD/IVC and the IPM/Camino

Experimental Group

Study Group 2: Therapeutic CSF drainage as appropriate, with EVD/IVC closure and ICP assessment approximately every 12 hours with simultaneous IPM/Camino ICP measurements collected.

Device: EVD/IVC and the IPM/Camino

Interventions

EVD/IVC and the IPM/Camino DEVICE

This is an interventional device study utilizing the EVD/IVC and the IPM/Camino to provide and evaluate data for optimized treatment for the control of elevated ICP and CCP in patients with severe TBI.

Experimental Group; Standard of Care Group

Eligibility Criteria

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

Study Population

This is an interventional device study utilizing the EVD/IVC and the IPM/Camino to provide and evaluate data for optimized treatment for the control of elevated ICP and CCP in patients with severe TBI. Enrolled patients will be randomized to one of two study groups listed below following the consent process. Once a potential participant has consented to the study, we will use the excel random number generator function (randbetween(0,1)) to generate random numbers between 0 and 1 for each participant. If 0 is generated participants will be placed in Group 1 (Hourly EVD closures) and if 1 is generated, participants will be placed in Group 2 (EVD closure every 12 hours). There is no placebo or control group.

You may qualify if:

• Direct trauma admission to STC by ambulance or helicopter
• years and older
• Neurosurgical evaluation indicates placement of a EVD
• Diagnosis of severe traumatic brain injury (head AIS \> 2) and post-resuscitation motor CGS\<6

You may not qualify if:

• \< 18 years of age
• Non-survivable brain injury
• Non-survivable anatomic injury
• Pregnancy
• Non-English speaker
• Prisoner
• Active duty military

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• United States Air Force: collaborator

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Neurotrauma Critical Care; Chief, Section of Trauma Critical Care, R Adams Cowley Shock Trauma Center

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 22, 2016
• Study Start: December 1, 2018
• Primary Completion: January 24, 2019
• Study Completion: January 24, 2019
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share