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New treatment option for Moderate to Severe Traumatic Brain Injury
Official title FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial
ClinicalTrials.gov ID: NCT06062888
What this study is testing
What is Fresh Frozen Plasma (FFP)?
Fresh Frozen Plasma (FFP) is an investigational medicine, being studied as a potential treatment for moderate to severe traumatic brain injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn about treatment with fresh frozen plasma (FFP) in individuals with moderate to severe traumatic brain injury. The two main question(s)it aims to answer are: Is the FFP treatment safe?
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male or female between the ages of 18 and 65 years
- Moderate to severe TBI: GCS 3-12
- Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG 3).
- The potential participant's wallet, when present, was examined and no power of attorney related to blood product administration was identified.
You likely can't join if
- Persons with a known history of adverse reaction to plasma products.
- Persons with a known history of congestive heart failure, renal failure, liver failure, or severe respiratory dysfunction requiring home use of...
- Persons who are currently incarcerated.
- Persons with inadequate venous access.
- Treatment cannot start within 1 hour of arrival at the hospital.
- The time of injury is unknown.
See the full eligibility criteria
- Male or female between the ages of 18 and 65 years
- Moderate to severe TBI: GCS 3-12
- Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG 3).
- The potential participant's wallet, when present, was examined and no power of attorney related to blood product administration was identified.
- Persons with a known history of adverse reaction to plasma products.
- Persons with a known history of congestive heart failure, renal failure, liver failure, or severe respiratory dysfunction requiring home use of supplemental oxygen.
- Persons who are currently incarcerated.
- Persons with inadequate venous access.
- Treatment cannot start within 1 hour of arrival at the hospital.
- The time of injury is unknown.
- Non-survivable injuries in the estimation of the attending trauma and/or neurosurgeon.
- Interfacility transfers
- Class 3 hemorrhagic shock
- Persons with known "do not resuscitate" orders prior to randomization
- Persons who refuse the administration of blood products
- Persons with a research "opt out" bracelet
- Persons who require FFP for any other indication (e.g., reversal of coagulopathy)
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.