Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding
- Conditions
- Bleeding Active
- Interventions
- Device: CELSTATDevice: Surgicel Original
- Registration Number
- NCT02640235
- Lead Sponsor
- Baxter Healthcare Corporation
- Brief Summary
The study is to evaluate the effectiveness and safety of CELSTAT vs active control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
Preoperative
- Subject is undergoing planned cardiothoracic, general or vascular surgery
Intraoperative
- Mild or moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after standard conventional surgical hemostatic methods prove to be ineffective or impractical.
Preoperative
- Subject needs emergency surgery
- Subject will undergo renal transplantation, or minimally invasive/laparoscopic surgery
- Subject will undergo neurological or ophthalmological surgery
- Subject will undergo urological or gynecological surgery
- Subject has congenital coagulation disorder
- Subject is pregnant or lactating at the time of enrollment, or becomes pregnant prior to the planned surgery
Intraoperative:
- Occurrence of any surgical complication that requires resuscitation or deviation from the planned surgical procedure prior to identification of target bleeding site
- Disseminated intravascular coagulopathy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CELSTAT CELSTAT Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original Surgicel Original Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
- Primary Outcome Measures
Name Time Method Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application 5 minute (post-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.
Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration Day 1 to Day 91 Findings are reported in this outcome measure and would have also been reported as an AE.
- Secondary Outcome Measures
Name Time Method Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application 3 minutes (post 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.
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application 10 minutes (post 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.
Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application 7 minutes (post 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.
Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis 0 to 10 minutes (post-application) If intraoperative re-bleeding occurred, the primary endpoint was considered "treatment failure."
Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious) Day 1 to Day 91 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 to Final Hemostasis at Target Bleeding Site by Percentage of Participants 0 to 10 minutes (post-application) 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).
Trial Locations
- Locations (25)
Infectious Disease of Indiana, PSC
🇺🇸Carmel, Indiana, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Non-Public Specialist Healthcare Facility "MEDICUS"
🇵🇱Sroda Wielkopolska, Poland
Independent Public Teaching Hospital #2, Department of Vascular and General Surgery and Angiology
🇵🇱Szczecin, Poland
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
University of Kentucky College of Medicine, Kentucky Clinic
🇺🇸Lexington, Kentucky, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
River City Clinical Research
🇺🇸Jacksonville, Florida, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
MCVI at Covenant Medical Center
🇺🇸Saginaw, Michigan, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Texas Heart Institute, Baylor St. Luke's Medical Center
🇺🇸Houston, Texas, United States
University Hospital Kralovske Vinohrady, Clinic of Surgery
🇨🇿Prague, Czechia
DRK Clinics Berlin, Clinic of Surgery
🇩🇪Berlin, Germany
University Hosptial Kralovske Vinohrady, Clinic of Cardiac Surgery
🇨🇿Prague, Czechia
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Florida College of Medicine
🇺🇸Gainesville, Florida, United States
Truman Medical Center
🇺🇸Kansas City, Missouri, United States
University of North Texas Science Center
🇺🇸Fort Worth, Texas, United States
Christ Hospital, Carl and Edyth Lindner Research Center
🇺🇸Cincinnati, Ohio, United States
Lake Washington Vascular
🇺🇸Bellevue, Washington, United States
Froedtert & The Medical College of Wisconsin Clinical Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Johann Wolfgang Goethe University Hospital, Clinic of General and Visceral Surgery
🇩🇪Frankfurt-am-Main, Germany
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States