Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243243
Status:
COMPLETED
Last Update Posted:
2016-05-26
First Post:
2005-10-19
Brief Title:
Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn
Sponsor:
United States Army Institute of Surgical Research
Organization:
United States Army Institute of Surgical Research
Study Overview
Official Title:
Effect of Recombinant Coagulation Factor VIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn Excision and Grafting
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:
None
Brief Summary:
The purpose of the study is to see if a medication Recombinant Coagulation Factor VIIa or NovoSeven normally used to stop bleeding in persons with a bleeding disorder will lower the amount of blood lost during burn surgery
Detailed Description:
To identify the clinical use for Factor VIIa in the operating room to reduce blood loss and blood transfusion determine the Recombinant Factor VIIa rFVIIa pharmacokinetics in burned patients determine if fFVIIa should be used to reduce peri-operative blood loss in patients undergoing excision greater than or equal to 20 percent of the total body surface area determine the efficacy of the drug in burned patients undergoing excision of burn wounds
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