FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

Moderate to Severe Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06062888
• Other study ID #: STU00218211
• Secondary ID: CDMRP-W81XWH2211
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: August 2024
• Est. completion date: September 2027

Study information

• Verified date: May 2024
• Source: Northwestern University
• Contact: Hasan Alam, MD
• Phone: 312-926-4962
• Email: Hasan.Alam[@]nm.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 264
• Est. completion date: September 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female between the ages of 18 and 65 years

2. Moderate to severe TBI: GCS 3-12

3. Cerebral contusion confirmed on the initial CT scan with Brain Injury Guidelines (BIG) = 3 (corresponding to lesion = 8 mm )

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)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Moderate to Severe Traumatic Brain Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Northwestern University	Medical College of Wisconsin, Oregon Health and Science University, University of Alabama at Birmingham, University of California, Davis, University of Southern California, University of Texas Southwestern Medical Center, Vanderbilt University Medical Center

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disability Rating Scale (DRS)	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.	6 months post-injury
Other	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.	6 months post-injury
Other	Time to treatment	Time to treatment measured in hours and minutes.	The first 24 hours post-injury
Other	Contusion volume	Total contusion volume measured in mm3	The first 24 hours post-injury
Other	Non-contiguous contusions	Count of non-contiguous contusions	The first 24 hours post-injury
Other	Glasgow Coma Scale (GCS)	This scale uses three behavior categories to measure response with larger numbers and total score representing a better outcome. They are: Eye opening response (4-1), Best verbal response (5-1) and Best motor response (6-1). Of the total score 15=Best response, 8 or less = Comatose client and 3=Totally unresponsive.	The first 24 hours post-injury
Other	TBI severity sub-stratification using the Glasgow Coma Scale (GCS)	his scale uses three behavior categories to measure response with larger numbers and total score representing a better outcome. They are: Eye opening response (4-1), Best verbal response (5-1) and Best motor response (6-1). Of the total score 15=Best response, 8 or less = Comatose client and 3=Totally unresponsive. (GCS 9-12) = moderate and (GCS 3-8)=severe	The first 24 hours post-injury
Primary	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	Hemorrhagic progression of the contusion (HPC)	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.	The first 24 hour post-injury
Secondary	Disability Rating Scale (DRS)	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.	Discharge or day 7 of the hospital stay and 3 months post-injury