Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding

Study Overview
=================
Brief Summary
-----------------
The study is to evaluate the effectiveness and safety of CELSTAT vs active control.

Official 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.

Conditions
-----------------
Bleeding Active

Intervention / Treatment
-----------------
* Device: CELSTAT
* Device: Surgicel Original


Participation Criteria
=================
Eligibility Criteria
-----------------
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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CELSTAT<br>Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site | Device: CELSTAT<br> <br> |
| Active Comparator: Surgicel Original<br>Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site | Device: Surgicel Original<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemostasis, Oxidized Cellulose Strip, Traumacel, Traumastem, Cardiothoracic Surgery, General Surgery, Vascular Surgery