Moderate to Severe Traumatic Brain Injury
Conditions
Keywords
TBI, Traumatic Brain Injury, Fresh frozen plasma, FFP
Brief summary
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? * Does the FFP treatment impact the 24-hour, 3-month and 6-month outcomes, intensive-care free days, mortality, and hospital brain and physical function at discharge. Patients with moderate to severe TBI will randomly receive either: * Standard of care treatment * Standard of care treatment + 2 units of FFP. Researchers will compare participants receiving standard of care treatment to those receiving experimental fresh frozen plasma (FFP) treatment to see if the FFP is safe and beneficial to participant outcomes.
Detailed description
The two units of fresh frozen plasma will consist of 400-500 ml. The 24-hour, 3-month and 6-month outcome measures include hemorrhagic progression of contusion (HPC) measured on 24-hour follow-up CT scan, the Disability Rating Score (DRS), 24-hour Glasgow Coma Scale (GCS) and the 3-month and 6-month Extended Glasgow Outcome Score (GOS-E). A third sub aim of the trial is to establish peripheral blood biomarkers, and radiographic features on the initial cross- sectional imaging, that could identify the optimal target population and predict the response to treatment.
Interventions
BIOLOGICALFresh Frozen Plasma (FFP)
Standard of Care + 2 units (400-500 ml) of fresh frozen plasma
Sponsors
Northwestern University
Vanderbilt University Medical Center
University of Southern California
Oregon Health and Science University
Medical College of Wisconsin
University of Texas Southwestern Medical Center
University of California, Davis
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Control vs Experimental Biologic Group
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female between the ages of 18 and 65 years 2. Moderate to severe TBI: GCS 3-12 3. Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG 3). 4. The potential participant's wallet, when present, was examined and no power of attorney related to blood product administration was identified.
Exclusion criteria
1. Persons with a known history of adverse reaction to plasma products. 2. Persons with a known history of congestive heart failure, renal failure, liver failure, or severe respiratory dysfunction requiring home use of supplemental oxygen. 3. Persons who are currently incarcerated. 4. Persons with inadequate venous access. 5. Treatment cannot start within 1 hour of arrival at the hospital. 6. The time of injury is unknown. 7. Non-survivable injuries in the estimation of the attending trauma and/or neurosurgeon. 8. Interfacility transfers 9. Class 3 hemorrhagic shock 10. Persons with known "do not resuscitate" orders prior to randomization 11. Persons who refuse the administration of blood products 12. Persons with a research "opt out" bracelet 13. Persons who require FFP for any other indication (e.g., reversal of coagulopathy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extended Glasgow Outcome Scale (GOS-E) | 3 months | Scoring values range from 1 to 8 with higher scores representing a better outcome. 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemorrhagic progression of the contusion (HPC) | The first 24 hour post-injury | We will quantify HPC as the change in volume of the largest contiguous brain lesion in mm. This will be measured through a comparison of the initial and the follow-up CT scan. |
| Disability Rating Scale (DRS) | Discharge or day 7 of the hospital stay and 3 months post-injury | This scale includes eight categories: A. Eye opening (0-5), B. Communication ability (0-4), C. Motor response (0-5), D. Feeding - cognitive ability only (0-3), E. Toileting - cognitive ability only (0-3), F. Grooming - cognitive ability only (0-3), G. Level of functioning - physical, mental, emotional or social function (0-5) and H. "Employability" - a full time worker, homemaker, or student (0-3). Higher scores in each category mean a worse outcome. |
Countries
United States
Contacts
CONTACTHasan Alam, MD
CONTACTNicole Meredyth, MD
PRINCIPAL_INVESTIGATORHasan Alam, MD
Northwestern University
Outcome results
None listed