The study is to evaluate the effectiveness and safety of CELSTAT vs active control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
260
Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application
Hemostasis is a process to prevent and stop bleeding within damaged blood vessels. Once the product(s) is applied it absorbs blood, turns brown, and adheres to the wound, thereby preventing thrombocytes from being washed out and accelerating hemostasis. Target bleeding sites include mild to moderate parenchymal (organ tissue),vascular (small arteries or veins or surgical reconnections) and soft tissue (muscle, fat, ligament, connective tissue) bleeding.
Time frame: 5 minute (post-application)
Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration
Findings are reported in this outcome measure and would have also been reported as an AE.
Time frame: Day 1 to Day 91
Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants
Data presented is an interpretation of a Kaplan-Meier plot based on quartiles of the survival distribution estimate. "Survival" times need not relate to actual survival with death being the event; the "event" may be any event of interest. The Kaplan-Meier curves and estimates of survival data have become a familiar way of dealing with differing survival times (times-to-event).
Time frame: 0 to 10 minutes (post-application)
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
Time frame: 3 minutes (post application)
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application
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Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Florida College of Medicine
Gainesville, Florida, United States
River City Clinical Research
Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Infectious Disease of Indiana, PSC
Carmel, Indiana, United States
University of Kentucky College of Medicine, Kentucky Clinic
Lexington, Kentucky, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
MCVI at Covenant Medical Center
Saginaw, Michigan, United States
...and 15 more locations
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
Time frame: 7 minutes (post application)
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application
The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.
Time frame: 10 minutes (post application)
Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis
If intraoperative re-bleeding occurred, the primary endpoint was considered "treatment failure."
Time frame: 0 to 10 minutes (post-application)
Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious)
Adverse Events (AEs) that occurred after the start of study treatment application are referred to as "treatment-emergent AEs" (TEAE). Timeframe for tracking AE's up to Day 91 (minus/plus 10 days=from Day 81 to Day 101).
Time frame: Day 1 to Day 91