Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-24 @ 4:44 PM
Study NCT ID:
NCT02750150
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2016-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Freeze-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients
Sponsor:
University Hospital, Lille
Organization:
Study Overview
Official Title:
A Randomized Trial to Evaluate Freezed-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TrauCC
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-A00075-38 | OTHER | ID-RCB number, ANSM | View |