NCT03609333

Brief Summary

Hypoxic ischemic brain injury is a devastating illness that occurs after cardiac arrest (the heart stopping) and can yield irreversible brain damage, often leading to death. The mainstay in therapy is to optimize the delivery of oxygen to the brain to help it recover. In patients with traumatic brain injury (similar to HIBI), the investigators are able to optimize oxygen delivery to the brain with the use of wires placed into the brain that sense the pressure and oxygen in the skull to find the ideal blood pressure for each individual patient. This strategy is associated with improved outcomes. The investigators are conducting a prospective study investigating whether the perfusion within proximity to the optimal MAP is associated with improved brain oxygenation and blood flow .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

3.6 years

First QC Date

July 25, 2018

Last Update Submit

November 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cerberal blood flow

    mls/100g/min

    12 hours

Study Arms (1)

Internal arm

EXPERIMENTAL
Device: Multimodal Neuromonitoring

Interventions

Application of multimodal neuromonitoring

Also known as: Targeted optimal MAP resuscitation
Internal arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed cardiac arrest with return of spontaneous circulation \> 10 minutes
  • post resuscitation GCS \< 9

You may not qualify if:

  • concurrent coagulopathy
  • prior history of TBI, intracranial hemorrhage, subarachnoid hemorrhage
  • anticipated cardiac catheterization within next 7 days
  • anticipated or current use of anticoagulants or anit-platelets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (2)

  • Sekhon MS, Ainslie PN, Menon DK, Thiara SS, Cardim D, Gupta AK, Hoiland RL, Gooderham P, Griesdale DE. Brain Hypoxia Secondary to Diffusion Limitation in Hypoxic Ischemic Brain Injury Postcardiac Arrest. Crit Care Med. 2020 Mar;48(3):378-384. doi: 10.1097/CCM.0000000000004138.

  • Sekhon MS, Griesdale DE, Ainslie PN, Gooderham P, Foster D, Czosnyka M, Robba C, Cardim D. Intracranial pressure and compliance in hypoxic ischemic brain injury patients after cardiac arrest. Resuscitation. 2019 Aug;141:96-103. doi: 10.1016/j.resuscitation.2019.05.036. Epub 2019 Jun 8.

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Mypinder Sekhon, MD

    UBC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 1, 2018

Study Start

November 12, 2016

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Locations