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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-MB200032 | Other Identifier | USAMRAA |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The investigators propose a prospective randomized trial to study fresh frozen plasma (FFP) versus albumin to determine the optimal colloid in burn resuscitations. This work addresses both FY20 focus areas, prolonged field care (PFC) and en route care, along with mitigating secondary effects of acute intervention, such as prevention of over resuscitation. Future military conflicts anticipate more extensive burn and blast injuries, and delayed evacuation. Therefore, the direct comparison of colloids used in burn resuscitation is critical to advancing battlefield medicine. Specifically, this work will provide the foundation for the use of freeze-dried plasma (FDP) in burn care by medical responders in PFC and en route care scenarios. The investigators hypothesize that FFP administration, and later FDP, in burn resuscitation is as safe as albumin, and more efficacious, in both reducing the total volume of fluid required in acute burn resuscitation and correcting burn endotheliopathy.
Specific Aim 1: The investigators will evaluate the total fluids administered in FFP (intervention) and albumin (control) groups. The investigators propose that the FFP group will require less total fluids administered.
Specific Aim 2:The investigators will determine overall complication rates (pulmonary complications, ARDS, ACS, over-resuscitation) in the FFP (intervention) and albumin (control) administration groups. The investigators propose FFP administration will reduce the frequency of these complications.
Specific Aim 3: The investigators will characterize the effects of FFP and albumin administration on endothelial dysfunction in major burns. We will measure glycocalyx degradation products (e.g. syndecan-1, glycosaminoglycans) in the serum. The investigators project FFP will mitigate GDP better than albumin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fresh Frozen Plasma | Active Comparator | At 6-8 hours, Initiate FFP infusion |
|
| Albumin | Active Comparator | At 7 hours, Initiate 5% Albumin infusion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fresh Frozen Plasma | Other | Fresh Frozen Plasma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total volume of fluid administered in 24 hours in each group (FFP or albumin), measured as mL/kg/%TBSA burned. | Total volume | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
Data will be compiled and shared with Department of Defense
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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