Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328133
Status:
COMPLETED
Last Update Posted:
2012-05-10
First Post:
2006-05-17
Brief Title:
The Use of rFVIIa in Trauma Patients A Multi-Center Case Registry
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
The Use of rFVIIa in Trauma Patients A WTAAAST Multi-Center Case Registry
Status:
COMPLETED
Status Verified Date:
2012-05
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:
Trauma surgeons throughout the US have begun using recombinant activated factor VII rFVIIa to control severe hemorrhage following injury when traditional measures have failed Despite promising results from several small studies there remain several unanswered questions regarding the use of this relatively expensive product in injured patients including
The timing of administration
Selection of appropriate patients who are most likely to benefit
The effective dose in injured patients
The potential need for repeated dosing
The need for administration of platelets and correction of acidosis prior to administering the first dose
The risks associated with the use of rFVIIa including venous andor arterial thrombosis
The potential for rFVIIa to cause or aggravate post-injury organ failure andor infectious complications
An analysis of cost versus benefit The purpose of this study is to collect a large sample of patients from multiple institutions in order to address the issues listed above To this end the Western Trauma Association Foundation is sponsoring a multi-center case registry for patients receiving rFVIIa for treatment of uncontrolled hemorrhage
The timing of administration
Selection of appropriate patients who are most likely to benefit
The effective dose in injured patients
The potential need for repeated dosing
The need for administration of platelets and correction of acidosis prior to administering the first dose
The risks associated with the use of rFVIIa including venous andor arterial thrombosis
The potential for rFVIIa to cause or aggravate post-injury organ failure andor infectious complications
An analysis of cost versus benefit The purpose of this study is to collect a large sample of patients from multiple institutions in order to address the issues listed above To this end the Western Trauma Association Foundation is sponsoring a multi-center case registry for patients receiving rFVIIa for treatment of uncontrolled hemorrhage
Detailed Description:
This is a prospective multi-center case registry that seeks to combine the collective experience with the use of rFVIIa at UCSFSFGH with other trauma centers The study is being conducted under the auspices of the Western Trauma Association and the American Association of the Surgery of Trauma Both organizations have a long history of successfully completing multi-center studies The outcomes to be used in this study are 1 survival 2 amount of blood products infused before and after rFVIIa 3 coagulation factors PTT INR before and after and 4 the surgeons assessment of hemostasis Data will also be analyzed to determine the cost effectiveness of rFVIIa when compared with other methods of treating severe hemorrhage primarily administration of blood products Finally the incidence of complications and thrombotic events after drug administration will be evaluated
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