Surgical Hemostasis
Conditions
Keywords
hemostasis, surgery, hemostatics, randomized controlled trial, phase 3
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 1:1 ratio to receive rhThrombin (1000 U/mL) or bovine thrombin (1000 U/mL). 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 site(s) 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.
Interventions
BIOLOGICALrThrombin
1000 U/mL applied topically in combination with absorbable gelatin sponge
DRUGbovine thrombin
1000 U/mL applied topically in combination with absorbable gelatin sponge
Sponsors
ZymoGenetics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access
Exclusion criteria
* Subject has undergone a therapeutic surgical procedure within 30 days prior to surgery * Subject has history of heparin-induced thrombocytopenia * Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors or known sensitivity to other components of the study treatment * Subject has received blood products within 24 hours prior to surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes | 10 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events | Up to 29 days |
| Incidence and grade of clinical laboratory abnormalities | Up to 29 days |
| Incidence of anti-product antibodies | Up to 29 days |
Countries
United States
Outcome results
None listed