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Lack of financial support
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Trauma is the leading cause of death in young people. Trauma-induced coagulopathy (TIC) encompasses several aspects of traumatic bleeding. Monitoring of coagulopathy comprises use of Point-of-Care (POC) methods, such as thromboelastography (TEG) or Thromboelastometry (ROTEM) and conventional laboratory assays (platelet count, fibrinogen level, and PT or INR).
POC tests are thought to have a better performance on mortality and bleeding control than conventional tests. The aim of this study is to compare POC and conventional assays with plasma consumption as a primary outcome and 28 days mortality as a secondary one.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POC group | Experimental | In this group, patients will be treated according to the information gathered by TEG or ROTEM assays. |
|
| Conventional group | Experimental | In this group, patients will be treated according to the information gathered by conventional laboratory assays (platelet count, fibrinogen level, PT or INR and d dimer for fibrinolysis) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trauma-induced coagulopathy treatment | Procedure | Transfusion as needed according to the assay methodology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fresh frozen plasma consumption | In the POC group plasma consumption is estimated 20% less than in conventional assays group | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 28 days mortality | 28 days |
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Inclusion Criteria: all adult (> 18 years old) trauma patients treated in our Emergency Department with a TASH score > 18
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Papa Giovanni XXIII | Bergamo | BG | 24127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27894492 | Background | Gonzalez E, Moore EE, Moore HB. Management of Trauma-Induced Coagulopathy with Thrombelastography. Crit Care Clin. 2017 Jan;33(1):119-134. doi: 10.1016/j.ccc.2016.09.002. | |
| 26720428 | Background | Gonzalez E, Moore EE, Moore HB, Chapman MP, Chin TL, Ghasabyan A, Wohlauer MV, Barnett CC, Bensard DD, Biffl WL, Burlew CC, Johnson JL, Pieracci FM, Jurkovich GJ, Banerjee A, Silliman CC, Sauaia A. Goal-directed Hemostatic Resuscitation of Trauma-induced Coagulopathy: A Pragmatic Randomized Clinical Trial Comparing a Viscoelastic Assay to Conventional Coagulation Assays. Ann Surg. 2016 Jun;263(6):1051-9. doi: 10.1097/SLA.0000000000001608. |
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| ID | Term |
|---|---|
| D009104 | Multiple Trauma |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
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Pragmatic randomized controlled trial
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| 25686465 | Background | Hunt H, Stanworth S, Curry N, Woolley T, Cooper C, Ukoumunne O, Zhelev Z, Hyde C. Thromboelastography (TEG) and rotational thromboelastometry (ROTEM) for trauma induced coagulopathy in adult trauma patients with bleeding. Cochrane Database Syst Rev. 2015 Feb 16;2015(2):CD010438. doi: 10.1002/14651858.CD010438.pub2. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |