NCT06062888

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
357

participants targeted

Target at P75+ for phase_2

Timeline
37mo left

Started Feb 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Feb 2026Jun 2029

First Submitted

Initial submission to the registry

September 13, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
2.3 years until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

September 13, 2023

Last Update Submit

February 9, 2026

Conditions

Moderate to Severe Traumatic Brain Injury

Keywords

TBITraumatic Brain InjuryFresh frozen plasmaFFP

Outcome Measures

Primary Outcomes (1)

  • Extended Glasgow Outcome Scale (GOS-E)

    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.

    3 months

Secondary Outcomes (2)

  • Hemorrhagic progression of the contusion (HPC)

    The first 24 hour post-injury

  • Disability Rating Scale (DRS)

    Discharge or day 7 of the hospital stay and 3 months post-injury

Other Outcomes (7)

  • Disability Rating Scale (DRS)

    6 months post-injury

  • Extended Glasgow Outcome Scale (GOS-E)

    6 months post-injury

  • Time to treatment

    The first 24 hours post-injury

  • +4 more other outcomes

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard of Care Control Group

Standard of Care + FFP

EXPERIMENTAL

Standard of Care + Experimental Treatment

Biological: Fresh Frozen Plasma (FFP)

Interventions

Fresh Frozen Plasma (FFP)BIOLOGICAL

Standard of Care + 2 units (400-500 ml) of fresh frozen plasma

Standard of Care + FFP

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (3)

  • 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: 38940059BACKGROUND

  • 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. doi: 10.1097/TA.0000000000003554. Epub 2022 Mar 28.

    PMID: 35343931BACKGROUND

  • 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: 39733294DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Hasan Alam, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hasan Alam, MD

CONTACT

312-926-4962Hasan.Alam@nm.org

Nicole Meredyth, MD

CONTACT

312-694-4867nicole.meredyth@nm.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Control vs Experimental Biologic Group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Surgery

Study Record Dates

First Submitted

September 13, 2023

First Posted

October 2, 2023

Study Start

February 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations

US(1)