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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-W81XWH2211106 | Other Grant/Funding Number | United States Department of Defense |
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| Name | Class |
|---|---|
| Vanderbilt University Medical Center | OTHER |
| University of Southern California | OTHER |
| Oregon Health and Science University | OTHER |
| Medical College of Wisconsin |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Standard of Care Control Group | |
| Standard of Care + FFP | Experimental | Standard of Care + Experimental Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fresh Frozen Plasma (FFP) | Biological | Standard of Care + 2 units (400-500 ml) of fresh frozen plasma |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Disability Rating Scale (DRS) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hasan Alam, MD | Contact | 312-926-4962 | Hasan.Alam@nm.org | |
| Nicole Meredyth, MD | Contact | 312-694-4867 | nicole.meredyth@nm.org |
| Name | Affiliation | Role |
|---|---|---|
| Hasan Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38940059 | Background | 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. | |
| 35343931 | Background | 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. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
| University of Texas Southwestern Medical Center | OTHER |
| University of California, Davis | OTHER |
| University of Alabama at Birmingham | OTHER |
Control vs Experimental Biologic Group
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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 |
| 6 months post-injury |
| 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 |
| Time to treatment | Time to treatment measured in hours and minutes. | The first 24 hours post-injury |
| Contusion volume | Total contusion volume measured in mm3 | The first 24 hours post-injury |
| Non-contiguous contusions | Count of non-contiguous contusions | The first 24 hours post-injury |
| 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 |
| 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 |
| 39733294 | Derived | 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. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |