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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A00075-38 | Other Identifier | ID-RCB number, ANSM |
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Knowledge and management of bleeding in severe trauma has changed. A specific coagulopathy is present in 40% of cases. It has a very early onset and this coagulopathy is associated with increased mortality. It must be detected and treated early, as illustrated by the military medical data, from the Iraq war and civilian medicine. However, fresh frozen plasma (FFP) requires a thawing step.The French army has encouraged the development of a freeze-dried plasma of innovative because viral inactivation and universal blood grouping, well tolerated, with a reduced risk of TRALI. This sophisticated therapeutic product can be administered after 6 minutes of reconstitution without the need for cross-matching. Nevertheless, its used is currently reserved for military purpose in overseas operations and needs to be evaluated for civil use. To this end, the investigators need to evaluate the impact on coagulopathy of an immediate availability of plasma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Freezed-dried plasma | Experimental | transfusion of 4 units of freezed dried plasma when available in patients at risk pf massive bleeding (transfusion of 4 red blood cells units in the first 6 hours after trauma) |
|
| Fresh-frozen plasma | Active Comparator | transfusion of 4 units of fresh frozen plasma when available in patients at risk pf massive bleeding (transfusion of 4 red blood cells units in the first 6 hours after trauma) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freezed-dried plasma | Drug | early transfusion of 4 units of freezed dried plasma |
| |
| Measure | Description | Time Frame |
|---|---|---|
| fibrinogen concentration (clauss) | 45 minutes after the admission on day 1 after trauma |
| Measure | Description | Time Frame |
|---|---|---|
| time frame of transfusion of 4 plasma | time range between the intention to transfuse plasma and the end of transfusion of 4 plasma within the first 6 hours after admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sophie Susen, MD,PhD | University Hospital, Lille | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency unit, Salengro hospital, | Lille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29274254 | Result | Garrigue D, Godier A, Glacet A, Labreuche J, Kipnis E, Paris C, Duhamel A, Resch E, Bauters A, Machuron F, Renom P, Goldstein P, Tavernier B, Sailliol A, Susen S. French lyophilized plasma versus fresh frozen plasma for the initial management of trauma-induced coagulopathy: a randomized open-label trial. J Thromb Haemost. 2018 Mar;16(3):481-489. doi: 10.1111/jth.13929. Epub 2018 Jan 22. |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
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| Fresh-frozen plasma |
| Drug |
|
| D006425 |
| Hemic and Lymphatic Diseases |