Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245336
Status:
COMPLETED
Last Update Posted:
2009-03-09
First Post:
2005-10-25
Brief Title:
Study of Recombinant Human Thrombin for Bleeding During Surgery
Sponsor:
ZymoGenetics
Organization:
ZymoGenetics
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Controlled Comparative Efficacy and Safety Study of Topical Recombinant Human Thrombin rhThrombin and Thrombin-JMI Bovine Thrombin in Surgical Hemostasis
Status:
COMPLETED
Status Verified Date:
2009-03
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 this study is to determine whether recombinant human Thrombin rhThrombin is effective in stopping bleeding during surgery in comparison with bovine thrombin
Detailed Description:
This is a Phase 3 multiple site randomized double-blind controlled trial designed to evaluate the comparative efficacy and safety of rhThrombin and bovine thrombin in patients undergoing spinal surgery hepatic resection peripheral arterial bypass surgery or arteriovenous graft formation for hemodialysis access
After establishing eligibility subjects will be randomized in a 11 ratio to receive rhThrombin 1000 UmL or bovine thrombin 1000 UmL During a surgical procedure study participants will be treated with blinded study drug rhThrombin or bovine thrombin in combination with an absorbable gelatin sponge at appropriate bleeding evaluation sites and time to hemostasis TTH will be assessed for up to 10 minutes Bleeding appropriate for TTH evaluation is defined as mild to moderate bleeding either on its own or remaining after brisk bleeding has been controlled by standard surgical modalities Blinded study drug may also be used at additional appropriate bleeding sites Study participants will have follow-up visits at about 2 days and 1 month after surgery Approximately 400 to 600 patients will participate in the study The final sample size will be determined based on blinded interim results
After establishing eligibility subjects will be randomized in a 11 ratio to receive rhThrombin 1000 UmL or bovine thrombin 1000 UmL During a surgical procedure study participants will be treated with blinded study drug rhThrombin or bovine thrombin in combination with an absorbable gelatin sponge at appropriate bleeding evaluation sites and time to hemostasis TTH will be assessed for up to 10 minutes Bleeding appropriate for TTH evaluation is defined as mild to moderate bleeding either on its own or remaining after brisk bleeding has been controlled by standard surgical modalities Blinded study drug may also be used at additional appropriate bleeding sites Study participants will have follow-up visits at about 2 days and 1 month after surgery Approximately 400 to 600 patients will participate in the study The final sample size will be determined based on blinded interim results
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