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Vasodilator
Inhaled Nitric Oxide for Traumatic Brain Injury
Phase 2
Waitlist Available
Led By Samuel Shin
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will test whether iNO can reduce TBI damage by increasing cerebral blood flow and improving patient outcomes.
Who is the study for?
Adults aged 18-75 with moderate traumatic brain injury (TBI), evidenced by specific criteria such as post-traumatic amnesia, loss of consciousness for a certain time, and particular radiologic findings. Patients both on breathing support and not are included. Excluded are those with severe heart issues, known large vessel brain disease, lung conditions like ARDS or pulmonary hypertension, serious kidney disease, immediate need for brain surgery, or pre-existing major psychiatric/neurological disorders.Check my eligibility
What is being tested?
The trial is testing inhaled nitric oxide (iNO), a gas that widens blood vessels to improve blood flow in the brain after TBI. Participants will be randomly assigned to receive iNO soon after their injury. The study will monitor changes in blood flow using optic neuromonitoring and measure recovery outcomes up to six months later.See study design
What are the potential side effects?
While the description doesn't list specific side effects of iNO treatment for this condition, common ones from other uses include headache, dizziness or lightheadedness due to low blood pressure from widened vessels; respiratory complications; and possibly increased bleeding risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brain Diseases, Metabolic
Secondary outcome measures
Traumatic injury
Hypotension
Methemoglobinemia
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment1 Intervention
Subjects will receive iNO for 4 hours, followed by standard respiratory support (SRS) for 4 hours. This pattern will be reversed the next day (SRS then iNO). on the following day, the pattern will be reversed back to iNO for 4 hours and SRS for 4 hrs.
Group II: Group AExperimental Treatment1 Intervention
Subjects will receive iNO for 4 hours, followed by standard respiratory support (SRS) for 4 hours. This pattern will be reversed the next day (SRS then iNO). on the following day, the pattern will be reversed back to iNO for 4 hours and SRS for 4 hrs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
inhaled nitric oxide
2009
Completed Phase 3
~400
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,050 Total Patients Enrolled
Samuel ShinPrincipal InvestigatorAssistant Professor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experienced memory loss for a day after an injury.I do not have severe heart problems.I currently have a respiratory infection.I have a large brain bleed.I needed CPR or a shock to my heart when I was admitted.I am either male or female.I am between 18 and 75 years old.My kidney function is reduced.I have a diagnosed brain blood vessel condition.I have ARDS or had high blood pressure in my lungs before.I am somewhat alert or fully alert with a concerning brain scan.I need surgery for a brain or nerve condition now.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Traumatic Brain Injury Patient Testimony for trial: Trial Name: NCT05616910 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the enrollment qualifications for this research endeavor?
"To participate in this medical study, applicants must have suffered traumatic brain injury and possess an age between 18 to 75 years. The total number of patients accepted is 38."
Answered by AI
Are there any opportunities for individuals to join this clinical trial?
"The profile on clinicaltrials.gov states that this trial is not actively seeking participants, despite being initially posted on August 1st 2023 and last modified November 8th 2022. However, there are still 899 other medical studies presently recruiting individuals for their trials."
Answered by AI
Is the eligibility criteria of this research limited to individuals aged 45 or younger?
"According to the prerequisites for this clinical trial, the minimum age of enrolment is 18 and there is an upper limit set at 75."
Answered by AI
Has Group B been granted approval by the Food and Drug Administration?
"Group B received a rating of 2 on the safety scale due to its status as a Phase 2 trial, which implies that there is sufficient evidence proving its security but not yet any data indicating its efficacy."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
Tennessee
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I want to optimize my recovery from TBI. Recovery has taken six months so far. Typically impatient patient. I’m a retired veterinarian, board certified in Comparative Medicine. Interest and experience in research medicine.
PatientReceived 1 prior treatment
Since my car accident, I have tried many treatment options, including pharmaceuticals, lifestyle changes, outpatient procedures. None of the options I have tried has been effective at managing the symptoms of my TBI/CTE from that accident. I feel that I have run out of options and a clinical trial is my last chance at returning to a normal life.
PatientReceived no prior treatments
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