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Trial record 22 of 314 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

Cortical Spreading Depolarization After Severe Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT03321370
Recruitment Status : Not yet recruiting
First Posted : October 25, 2017
Last Update Posted : October 25, 2017
Sponsor:
Collaborators:
David Darrow, MD, MPH
Thomas Bergman, MD
Tenbit Emiru, MD, PhD
Uzma Samadani, MD, PhD
Michael Park, MD, PhD
Information provided by (Responsible Party):
Samuel Cramer, Hennepin County Medical Center, Minneapolis

Brief Summary:
Preliminary evaluation of electrodes placed on the brain for recording brain activity and novel algorithms to determine cortical spreading depolarization foci of origination following severe traumatic brain injury requiring neurosurgical intervention.

Condition or disease Intervention/treatment
Traumatic Brain Injury Diagnostic Test: Continuous electrocorticography post severe traumatic brain injury requiring neurosurgical intervention

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cortical Spreading Depolarization After Severe Traumatic Brain Injury
Estimated Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Continuous electrocorticography post severe traumatic brain injury requiring neurosurgical intervention
    Continuous electrocorticography via subdural electrode strips for 1 to 3 weeks in the neuro intensive care unit following traumatic brain injury


Primary Outcome Measures :
  1. Determination of foci that give rise to cortical spreading depolarizations [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Determine the relationship between cortical spreading depolarization foci of origination and structural pathology demonstrated on brain imaging (CT and MRI). [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Determine the association (if any) between cortical spreading depolarization foci of origination and cortical spreading depolarization frequency with relevant physiological data. [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from the population of severe TBI patients clinically judged to require neurosurgical intervention who present through the emergency department or upon direct transfer to the neurosurgery service at Hennepin County Medical Center. The target sample size for this preliminary study is 10 subjects.
Criteria

Inclusion Criteria:

  • Patient recommended to undergo craniectomy or craniotomy for the treatment of acute TBI

Exclusion Criteria:

  • Wound determined to be contaminated
  • Decompression is performed only in the posterior fossa
  • Known systemic infection
  • Pregnancy

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): NCT03321370


Contacts
Contact: Samuel W Cramer, MD, PhD 612-624-6666 cram0080@umn.edu
Contact: David P Darrow, MD, MPH 612-624-6666 darro015@umn.edu

Sponsors and Collaborators
Hennepin County Medical Center, Minneapolis
David Darrow, MD, MPH
Thomas Bergman, MD
Tenbit Emiru, MD, PhD
Uzma Samadani, MD, PhD
Michael Park, MD, PhD
Investigators
Principal Investigator: Samuel W Cramer, MD, PhD University of Minnesota Neurosurgery Department; Division of Neurosurgery, Department of Surgery, Hennepin County Medical Center

Publications:
Dreier JP, Fabricius M, Ayata C, Sakowitz OW, William Shuttleworth C, Dohmen C, Graf R, Vajkoczy P, Helbok R, Suzuki M, Schiefecker AJ, Major S, Winkler MK, Kang EJ, Milakara D, Oliveira-Ferreira AI, Reiffurth C, Revankar GS, Sugimoto K, Dengler NF, Hecht N, Foreman B, Feyen B, Kondziella D, Friberg CK, Piilgaard H, Rosenthal ES, Westover MB, Maslarova A, Santos E, Hertle D, Sánchez-Porras R, Jewell SL, Balança B, Platz J, Hinzman JM, Lückl J, Schoknecht K, Schöll M, Drenckhahn C, Feuerstein D, Eriksen N, Horst V, Bretz JS, Jahnke P, Scheel M, Bohner G, Rostrup E, Pakkenberg B, Heinemann U, Claassen J, Carlson AP, Kowoll CM, Lublinsky S, Chassidim Y, Shelef I, Friedman A, Brinker G, Reiner M, Kirov SA, Andrew RD, Farkas E, Güresir E, Vatter H, Chung LS, Brennan KC, Lieutaud T, Marinesco S, Maas AI, Sahuquillo J, Dahlem MA, Richter F, Herreras O, Boutelle MG, Okonkwo DO, Bullock MR, Witte OW, Martus P, van den Maagdenberg AM, Ferrari MD, Dijkhuizen RM, Shutter LA, Andaluz N, Schulte AP, MacVicar B, Watanabe T, Woitzik J, Lauritzen M, Strong AJ, Hartings JA. Recording, analysis, and interpretation of spreading depolarizations in neurointensive care: Review and recommendations of the COSBID research group. J Cereb Blood Flow Metab. 2017 May;37(5):1595-1625. doi: 10.1177/0271678X16654496. Epub 2016 Jan 1. Review.

Responsible Party: Samuel Cramer, Neurosurgery Resident Physician, Hennepin County Medical Center, Minneapolis
ClinicalTrials.gov Identifier: NCT03321370     History of Changes
Other Study ID Numbers: HSR 17-4400
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System