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Recruiting NCT06062888

FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

Phase II / Phase III Interventional Moderate to Severe Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fresh Frozen Plasma (FFP).
Who it may be relevant to
Registry conditions: Moderate to Severe Traumatic Brain Injury. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multi-institutional Phase 2/3 Trial of Fresh Frozen Plasma (FFP) in Patients With Moderate to Severe Traumatic Brain Injury (TBI)

Overview

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

  • Biological Fresh Frozen Plasma (FFP)
    Standard of Care + 2 units (400-500 ml) of fresh frozen plasma

Primary outcome measures

  • Extended Glasgow Outcome Scale (GOS-E) [Time frame: 3 months]
Secondary outcome measures (2)
  • Hemorrhagic progression of the contusion (HPC) [Time frame: The first 24 hour post-injury]
  • Disability Rating Scale (DRS) [Time frame: Discharge or day 7 of the hospital stay and 3 months post-injury]

Eligibility criteria

Inclusion 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.

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Northwestern University — Chicago

Publications

  • Liggett MR, Lashley S, Gill NP, Scholtens DM, Dawood ZS, Alam HB. Plasma therapy for traumatic brain injury: Rationale for a prospective randomized trial. Transfusion. 2024 Jul;64(7):1362-1371. doi: 10.1111/trf.17928. Epub 2024 Jun 28. No abstract available. PMID 38940059
  • Joseph B, Obaid O, Dultz L, Black G, Campbell M, Berndtson AE, Costantini T, Kerwin A, Skarupa D, Burruss S, Delgado L, Gomez M, Mederos DR, Winfield R, Cullinane D; AAST BIG Multi-institutional Study Group. Validating the Brain Injury Guidelines: Results of an American Association for the Surgery of Trauma prospective multi-institutional trial. J Trauma Acute Care Surg. 2022 Aug 1;93(2):157-165. PMID 35343931
  • Jin G, Liggett MR, Ho JW, Dawood ZS, Chtraklin K, Diaz D, Alam HB. Plasma treatment is associated with decreased brain lesion and resuscitation requirements after traumatic brain injury in a swine model of prolonged damage-control resuscitation. J Trauma Acute Care Surg. 2024 Dec 1;97(6):954-960. doi: 10.1097/TA.0000000000004457. Epub 2024 Oct 15. PMID 39733294

Identifiers

NCT: NCT06062888 · PR212312 · CDMRP-W81XWH2211106

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗