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This is a randomized controlled trial to compare viscoelastic (VE) guided resuscitation to fixed-ratio resuscitation in trauma patients with hemorrhagic shock on the utilization of blood products, effects on coagulation and inflammatory mediators, and how these strategies affect post resuscitation adverse events.
This is an open labeled study as the VE guided resuscitation will be based on the visible VE results. Aim 1 will compare the number of blood products utilized in each resuscitation strategy. Aim 2 will analyze the coagulation and inflammatory mediators in each resuscitation strategy to determine if there is a difference in the mechanism of coagulopathy. Aim 3 will determine if the different resuscitation strategies have an effect on post resuscitation adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Massive Transfusion Protocol Guided | No Intervention | Clinicians will only transfuse patients according to standard massive transfusion protocol (MTP) | |
| Thromboelastometry guided transfusion | Experimental | Clinicians will transfuse patients according to ROTEM results. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thromboelastometry guided transfusion | Procedure | Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of blood products utilized at 24 hours | Number of blood products utilized during that time frame will be recorded to determine if change in resuscitation strategies result in measurable differences | 24 hours from time of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in coagulation profile | Analyze coagulation profiles in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy | 0 hours and 30 days |
| Change in inflammatory mediators |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael W. Cripps, M.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Memorial Hospital | Dallas | Texas | 75206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24103457 | Background | Schlimp CJ, Voelckel W, Inaba K, Maegele M, Schochl H. Impact of fibrinogen concentrate alone or with prothrombin complex concentrate (+/- fresh frozen plasma) on plasma fibrinogen level and fibrin-based clot strength (FIBTEM) in major trauma: a retrospective study. Scand J Trauma Resusc Emerg Med. 2013 Oct 8;21:74. doi: 10.1186/1757-7241-21-74. |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D020141 | Hemostatic Disorders |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
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Analyze inflammatory mediators in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy
| 0 hours and 30 days |
| Changes in Resuscitation strategy-related adverse events | Rate of resuscitation strategies-related adverse events as a composite, including (transfusion related acute lung injury, transfusion associated circulatory overload, hyperkalemia, hypocalcemia, allergic reaction, hemolysis and transfusion transmitted infection) | 30 days after admission |
| D006425 |
| Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |