Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627218
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Liberal or Adhere to Recommendations for PCC Management in Major Bleeding Following Trauma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Liberal or Adhere to Recommendations for Prothrombin Complex Concentrate Management in Major Bleeding Following TraumaA Multicenter Retrospective Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Severe post-traumatic bleeding remains a major challenge in trauma management The effectiveness and safety of PCC in the treatment of major traumatic bleeding is controversial and the indications for use are not clear Studies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking
Detailed Description:
Post-traumatic severe bleeding and associated traumatic coagulopathy remains a challenge
The use of prothrombin complex concentrate PCC is being explored in the management of on-going coagulopathy following trauma with the cited purpose of boosting thrombin generation Clinical data on the efficacy of PCC as part of a coagulation factor concentrate-based haemostatic strategy showed initial promising results in retrospective studies and meta-analysis
Certainly the utility of PCC was a residual question in the management of traumatic coagulopathy Uncertainty remains on the indication of useThe 2019 guideline on management of major bleeding and coagulopathy following trauma suggest that PCC should be administered to the bleeding patient based on evidence of delayed coagulation initiation using VEM provided that fibrinogen levels are normal The recommendation Grade is 2CStudies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking
The use of prothrombin complex concentrate PCC is being explored in the management of on-going coagulopathy following trauma with the cited purpose of boosting thrombin generation Clinical data on the efficacy of PCC as part of a coagulation factor concentrate-based haemostatic strategy showed initial promising results in retrospective studies and meta-analysis
Certainly the utility of PCC was a residual question in the management of traumatic coagulopathy Uncertainty remains on the indication of useThe 2019 guideline on management of major bleeding and coagulopathy following trauma suggest that PCC should be administered to the bleeding patient based on evidence of delayed coagulation initiation using VEM provided that fibrinogen levels are normal The recommendation Grade is 2CStudies on the status of PCC use and the efficacy evaluation of PCC adhere to recommendations are lacking
Study Oversight
Has Oversight DMC:
None
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?:
None