ICP only for Traumatic Brain Injury

Phase-Based Progress Estimates
University of North Carolina Medical Center, Chapel Hill, NCTraumatic Brain Injury+5 MoreICP + PbtO2 guided management strategy - Other
Any Age
All Sexes
What conditions do you have?

Study Summary

This trial will help doctors determine whether a treatment strategy guided by both intracranial pressure and brain tissue oxygen is more effective than one guided by intracranial pressure alone.

Eligible Conditions
  • Traumatic Brain Injury

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: 6 months

6 months
Cognition: Rey Auditory Verbal Learning Test
Cognition: Trail Making Test Part A+B
Cognition: WAIS IV Processing Speed Index
Cognition: WRAT-4 Reading Subtest
Emotional Health: Brief Symptom Inventory 18
Emotional Health: Rivermead Post-Concussion Symptom Questionnaire
Emotional Health: Satisfaction with Life Scale
Functional Status Exam
Glasgow Outcome Scale-Extended (GOS-E)
Day 19
Day 5
Total Brain Hypoxia Exposure

Trial Safety

Trial Design

2 Treatment Groups

ICP only
1 of 2
ICP + PbtO2
1 of 2

Active Control

1094 Total Participants · 2 Treatment Groups

Primary Treatment: ICP only · No Placebo Group · N/A

ICP only
ActiveComparator Group · 1 Intervention: ICP guided management strategy · Intervention Types: Other
ICP + PbtO2
ActiveComparator Group · 1 Intervention: ICP + PbtO2 guided management strategy · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

University of MichiganLead Sponsor
1,647 Previous Clinical Trials
6,419,353 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,271 Previous Clinical Trials
455,088 Total Patients Enrolled
University of WashingtonOTHER
1,612 Previous Clinical Trials
1,572,423 Total Patients Enrolled
University of PennsylvaniaOTHER
1,875 Previous Clinical Trials
41,147,625 Total Patients Enrolled
University of PittsburghOTHER
1,635 Previous Clinical Trials
16,306,410 Total Patients Enrolled
Medical University of South CarolinaOTHER
853 Previous Clinical Trials
5,389,072 Total Patients Enrolled
Ramon Diaz-Arrastia, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania, Philadelphia, PA 19104
11 Previous Clinical Trials
5,052 Total Patients Enrolled
William Barsan, MDPrincipal Investigator - University of Michigan, Ann Arbor, MI 48109
University of Michigan C.S. Mott Children's Hospital, University of Michigan Health System, Von Voigtlander Women's Hospital
Ohio State University College Of Medicine (Medical School)
University Hosp, Inc (Residency)
4 Previous Clinical Trials
2,012 Total Patients Enrolled
Sharon Yeatts, PhDPrincipal InvestigatorMedical University of South Carolina, Charleston, SC 29425
1 Previous Clinical Trials
511 Total Patients Enrolled
Lori Shutter, MDPrincipal InvestigatorUniversity of Pittsburgh, Pittsburgh, PA 15260
2 Previous Clinical Trials
57 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can have probes placed in your head and be randomized within 12 hours of your injury.
You have a head injury that did not break through the skull.

Frequently Asked Questions

Are there any opportunities still available to take part in this clinical experiment?

"Affirmative. The clinicaltrial.gov database states that this medical experiment, inaugural in late August 2019, is currently enrolling patients. 1094 individuals must be recruited from 35 distinct sites to successfully complete the trial." - Anonymous Online Contributor

Unverified Answer

How many test subjects are engaged in this experiment?

"As mandated by the inclusion criteria, 1094 willing participants are needed to complete this trial. Patients may sign up at Duke University Hospital in Durham or UPMC Presbyterian Hospital in Pittsburgh." - Anonymous Online Contributor

Unverified Answer

In what locations is this clinical experiment being conducted?

"The trial is taking place in an array of 35 sites which includes, but not limited to, Durham, Pittsburgh and Houston. For convenience purposes when signing up for the study it is recommended that you locate your nearest clinic to reduce travel time." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.