Bleeding Active
Conditions
Keywords
Hemostasis, Oxidized Cellulose Strip, Traumacel, Traumastem, Cardiothoracic Surgery, General Surgery, Vascular Surgery
Brief summary
The study is to evaluate the effectiveness and safety of CELSTAT vs active control.
Interventions
DEVICECELSTAT
DEVICESurgicel Original
Sponsors
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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). |
| 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 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. |
Countries
Czechia, Germany, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CELSTAT Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site
CELSTAT | 126 |
| Surgicel Original Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
Surgicel Original | 124 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 3 |
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Other | 1 | 2 |
| Overall Study | Withdrawal by Subject | 7 | 6 |
Baseline characteristics
| Characteristic | CELSTAT | Surgicel Original | Total |
|---|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 12.88 | 63.3 years STANDARD_DEVIATION 13.56 | 63.4 years STANDARD_DEVIATION 13.19 |
| Race/Ethnicity, Customized American Indian or | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African | 15 Participants | 12 Participants | 27 Participants |
| Race/Ethnicity, Customized Native Hawaiian or | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Applicable | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 108 Participants | 109 Participants | 217 Participants |
| Sex: Female, Male Female | 42 Participants | 48 Participants | 90 Participants |
| Sex: Female, Male Male | 84 Participants | 76 Participants | 160 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 133 | 3 / 127 |
| other Total, other adverse events | 72 / 133 | 68 / 127 |
| serious Total, serious adverse events | 27 / 133 | 23 / 127 |
Outcome results
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.
Time frame: 5 minute (post-application)
Population: PPS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CELSTAT | Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application | No | 32 Participants |
| CELSTAT | Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application | Yes | 94 Participants |
| Surgicel Original | Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application | Yes | 109 Participants |
| Surgicel Original | Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application | No | 15 Participants |
95% CI: [-15.6, -1.4]Regression, Logistic
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.
Time frame: Day 1 to Day 91
Population: Safety Analysis Set - all subjects who were treated with CELSTAT or Surgicel.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CELSTAT | Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration | 0 Participants |
| Surgicel Original | Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration | 0 Participants |
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).
Time frame: Day 1 to Day 91
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CELSTAT | Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious) | 289 events |
| Surgicel Original | Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious) | 244 events |
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.
Time frame: 10 minutes (post application)
Population: PPS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CELSTAT | Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application | Yes | 119 Participants |
| CELSTAT | Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application | No | 7 Participants |
| Surgicel Original | Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application | No | 4 Participants |
| Surgicel Original | Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application | Yes | 120 Participants |
95% CI: [-5.7, 4.3]Regression, Logistic
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.
Time frame: 3 minutes (post application)
Population: PPS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CELSTAT | Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application | Yes | 84 Participants |
| CELSTAT | Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application | No | 42 Participants |
| Surgicel Original | Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application | Yes | 79 Participants |
| Surgicel Original | Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application | No | 45 Participants |
95% CI: [-3.6, 13.1]Regression, Logistic
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.
Time frame: 7 minutes (post application)
Population: PPS
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CELSTAT | Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application | Yes | 108 Participants |
| CELSTAT | Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application | No | 18 Participants |
| Surgicel Original | Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application | Yes | 118 Participants |
| Surgicel Original | Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application | No | 6 Participants |
95% CI: [-12, -0.5]Regression, Logistic
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.
Time frame: 0 to 10 minutes (post-application)
Population: PPS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CELSTAT | Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis | Yes | 3.3 Percentage of Participants |
| CELSTAT | Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis | No | 96.7 Percentage of Participants |
| Surgicel Original | Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis | Yes | 2.5 Percentage of Participants |
| Surgicel Original | Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis | No | 97.5 Percentage of Participants |
95% CI: [-3.9, 4.4]Regression, Logistic
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).
Time frame: 0 to 10 minutes (post-application)
Population: PPS
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CELSTAT | Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants | 75% of Patients | 6 minutes |
| CELSTAT | Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants | 50% of Patients | 2 minutes |
| CELSTAT | Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants | 25% of Patients | 0.833 minutes |
| Surgicel Original | Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants | 75% of Patients | 4 minutes |
| Surgicel Original | Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants | 50% of Patients | 3 minutes |
| Surgicel Original | Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants | 25% of Patients | 1.292 minutes |