Bleeding Active Clinical Trial
— CELSTATOfficial title:
A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness and Safety of CELSTAT as an Adjunct to Hemostasis for Tissue Bleeding in Cardiothoracic, General, and Vascular Surgery.
| Verified date | July 2020 |
| Source | Baxter Healthcare Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The study is to evaluate the effectiveness and safety of CELSTAT vs active control.
| Status | Completed |
| Enrollment | 260 |
| Est. completion date | October 18, 2017 |
| Est. primary completion date | July 21, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: Preoperative 1. Subject is undergoing planned cardiothoracic, general or vascular surgery Intraoperative 1. 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. Exclusion Criteria: Preoperative 1. Subject needs emergency surgery 2. Subject will undergo renal transplantation, or minimally invasive/laparoscopic surgery 3. Subject will undergo neurological or ophthalmological surgery 4. Subject will undergo urological or gynecological surgery 5. Subject has congenital coagulation disorder 6. Subject is pregnant or lactating at the time of enrollment, or becomes pregnant prior to the planned surgery Intraoperative: 1. Occurrence of any surgical complication that requires resuscitation or deviation from the planned surgical procedure prior to identification of target bleeding site 2. Disseminated intravascular coagulopathy |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | University Hospital Kralovske Vinohrady, Clinic of Surgery | Prague | |
| Czechia | University Hosptial Kralovske Vinohrady, Clinic of Cardiac Surgery | Prague | |
| Germany | DRK Clinics Berlin, Clinic of Surgery | Berlin | |
| Germany | Johann Wolfgang Goethe University Hospital, Clinic of General and Visceral Surgery | Frankfurt-am-Main | |
| Poland | Non-Public Specialist Healthcare Facility "MEDICUS" | Sroda Wielkopolska | |
| Poland | Independent Public Teaching Hospital #2, Department of Vascular and General Surgery and Angiology | Szczecin | |
| United States | Lake Washington Vascular | Bellevue | Washington |
| United States | Infectious Disease of Indiana, PSC | Carmel | Indiana |
| United States | Carolinas Medical Center | Charlotte | North Carolina |
| United States | Christ Hospital, Carl and Edyth Lindner Research Center | Cincinnati | Ohio |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | University of North Texas Science Center | Fort Worth | Texas |
| United States | University of Florida College of Medicine | Gainesville | Florida |
| United States | Houston Methodist Hospital | Houston | Texas |
| United States | Texas Heart Institute, Baylor St. Luke's Medical Center | Houston | Texas |
| United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
| United States | River City Clinical Research | Jacksonville | Florida |
| United States | Truman Medical Center | Kansas City | Missouri |
| United States | University of Kentucky College of Medicine, Kentucky Clinic | Lexington | Kentucky |
| United States | Froedtert & The Medical College of Wisconsin Clinical Cancer Center | Milwaukee | Wisconsin |
| United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
| United States | MCVI at Covenant Medical Center | Saginaw | Michigan |
| United States | Baystate Medical Center | Springfield | Massachusetts |
| United States | Washington Hospital Center | Washington | District of Columbia |
| United States | University of Massachusetts Medical School | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Baxter Healthcare Corporation |
United States, Czechia, Germany, Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 5 minute (post-application) | |
| Primary | 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. | Day 1 to Day 91 | |
| Secondary | 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). | 0 to 10 minutes (post-application) | |
| Secondary | 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. | 3 minutes (post application) | |
| Secondary | Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 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. | 7 minutes (post application) | |
| Secondary | 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. | 10 minutes (post application) | |
| Secondary | 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." | 0 to 10 minutes (post-application) | |
| Secondary | 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). | Day 1 to Day 91 |