Fresh Frozen Plasma for Traumatic Brain Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether fresh frozen plasma (FFP), a blood product, can aid individuals with moderate to severe traumatic brain injury (TBI). Researchers aim to determine if FFP is safe and improves outcomes such as recovery time and overall brain function. Participants will receive either standard treatment or standard treatment plus FFP to compare results. The trial seeks individuals with a confirmed brain injury on a CT scan and no restrictions on receiving blood products. As a Phase 2, Phase 3 trial, this study is crucial for assessing FFP's effectiveness in a larger group and represents one of the final steps before potential FDA approval, offering participants a chance to contribute to groundbreaking research.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that fresh frozen plasma (FFP) could be a helpful treatment for traumatic brain injury (TBI). Studies suggest that FFP might improve recovery for people with severe head injuries. For instance, one study found that FFP could lower the risk of bleeding in the brain, a major concern for TBI patients.
In terms of safety, FFP is usually well-tolerated. Past patients have demonstrated that receiving plasma does not often lead to serious side effects. This indicates that using FFP is generally safe, with few people experiencing major problems. However, like any treatment, there may be risks, so discussing them with healthcare providers is important.
Overall, current evidence suggests that FFP is a safe option for TBI treatment, with potential benefits for improving patient recovery.12345Why do researchers think this study treatment might be promising?
Researchers are excited about using Fresh Frozen Plasma (FFP) for traumatic brain injury because it offers a unique approach compared to traditional treatments like supportive care and medications to reduce intracranial pressure. Unlike these standard treatments, FFP provides a concentrated source of clotting factors and proteins, which might help stabilize bleeding and improve recovery after head trauma. This approach targets the injury at a biochemical level, potentially reducing the extent of brain damage and speeding up the healing process.
What evidence suggests that fresh frozen plasma might be an effective treatment for traumatic brain injury?
Research suggests that fresh frozen plasma (FFP) might help treat traumatic brain injuries. In this trial, some participants will receive the standard of care plus FFP, while others will receive only the standard of care. Some studies have shown that giving patients more plasma compared to red blood cells can lower the risk of death in those with severe blunt traumatic brain injuries. This suggests that patients who receive more plasma may have a better chance of surviving. Other research indicates that FFP can help reduce a type of brain bleeding called DTICH in people with severe head injuries. However, not all studies agree on its effectiveness, so more research is needed to confirm these benefits.24567
Who Is on the Research Team?
Hasan Alam, MD
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
The FIT-BRAIN trial is for individuals with moderate to severe traumatic brain injury (TBI), confirmed by a CT scan showing a lesion of at least 8 mm. Participants must have a Glasgow Coma Scale score between 3 and 12, indicating the severity of their brain injury.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard of care treatment or standard of care treatment plus 2 units of fresh frozen plasma (FFP)
Follow-up
Participants are monitored for safety and effectiveness with outcome measures at 24 hours, 3 months, and 6 months post-injury
What Are the Treatments Tested in This Trial?
Interventions
- Fresh Frozen Plasma (FFP)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
University of Southern California
Collaborator
Oregon Health and Science University
Collaborator
University of Alabama at Birmingham
Collaborator
Vanderbilt University Medical Center
Collaborator
Medical College of Wisconsin
Collaborator
University of California, Davis
Collaborator
University of Texas Southwestern Medical Center
Collaborator