Cardiovascular Bleeding, Hemorrhage, Vascular Bleeding
Conditions
Brief summary
To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective vascular surgery.
Interventions
BIOLOGICALBioseal Fibrin Sealant
OTHERManual Compression
Sponsors
Guangzhou Bioseal Biotechnology Co., Ltd.
Ethicon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects between 18 and 75 years of age; 2. Undergoing elective vascular surgical procedures and with the presence of an appropriate Target Bleeding Site (TBS) requiring an adjunct to achieve hemostasis as identified intra-operatively by the surgeon ; 3. Able and willing to comply with procedures required by protocol; 4. Signed and dated written informed consent prior to any study related procedures.
Exclusion criteria
1. Subjects with any intra-operative findings that may preclude conducting of the study procedures; 2. Intended use of Fibrin Sealants (including autologous Fibrin Sealants) other than Bioseal on the TBS; 3. Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products; 4. Subjects with known allergies to or previously used porcine derived products; 5. Female subjects who are known breastfeeding or pregnant or intend to become pregnant during the clinical study period. 6. The subject, in the opinion of the investigator, would not be suitable for participation in the study. 7. Subjects who participated in another trial within 30 days prior to the planned start of treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application. | Intra-operative, 10 minutes following randomization | Percentage of participants with Hemostasis at the TBS at 10 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application | Intra-operative, 3 and 6 minutes following randomization | Percentage of participants with Hemostasis at the TBS at 3 and 6 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding. |
| Number of Participants Requiring Alternative Treatment Due to Treatment Failure* | Intra-operative, 10 minutes following randomization | Alternative treatments include the use of additional hemostatic methods, including collagen, manual compression, oxidized regenerated cellulose and suture. Manual compression (MC) may be applied after the initial 10 minute observation period as an alternative treatment due to treatment failure in either group. For participants with a treatment failure in MC group, the addition treatment of MC is applied after the initial 10 minute observation period. |
| Percentage of Participants With Potential Bleeding-related Adverse Events | 30-days follow-up | Percentage of participants with potential bleeding-related adverse events by study group |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bioseal Fibrin Sealant A porcine-derived fibrin sealant consisting of thrombin and fibrinogen. | 125 |
| Manual Compression Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants. | 127 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 5 |
| Overall Study | Withdrawn due to age | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Bioseal Fibrin Sealant | Manual Compression |
|---|---|---|---|
| Age, Continuous | 56.9 years STANDARD_DEVIATION 12.6 | 57.1 years STANDARD_DEVIATION 13 | 56.8 years STANDARD_DEVIATION 12.2 |
| Age, Customized >60,<=75 years | 123 Participants | 60 Participants | 63 Participants |
| Age, Customized <=60 years | 127 Participants | 63 Participants | 64 Participants |
| Age, Customized >75 | 2 Participants | 2 Participants | 0 Participants |
| BMI | 23.9 kg/m^2 STANDARD_DEVIATION 3.3 | 23.9 kg/m^2 STANDARD_DEVIATION 3.4 | 23.8 kg/m^2 STANDARD_DEVIATION 3.2 |
| BMI Group Normal | 154 participants | 75 participants | 79 participants |
| BMI Group Obese | 6 participants | 3 participants | 3 participants |
| BMI Group Overweight | 80 participants | 41 participants | 39 participants |
| BMI Group Underweight | 12 participants | 6 participants | 6 participants |
| Height | 166.9 cm STANDARD_DEVIATION 7.4 | 168.0 cm | 167.0 cm |
| Sex: Female, Male Female | 68 Participants | 35 Participants | 33 Participants |
| Sex: Female, Male Male | 184 Participants | 90 Participants | 94 Participants |
| Smoking Status Current Smoker | 70 participants | 39 participants | 31 participants |
| Smoking Status Former Smoker | 32 participants | 15 participants | 17 participants |
| Smoking Status Never Smoked | 150 participants | 71 participants | 79 participants |
| Weight | 66.0 kg | 67.1 kg STANDARD_DEVIATION 11.6 | 66.0 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 125 | 13 / 127 |
| serious Total, serious adverse events | 13 / 125 | 11 / 127 |
Outcome results
Primary
Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.
Percentage of participants with Hemostasis at the TBS at 10 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.
Time frame: Intra-operative, 10 minutes following randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bioseal Fibrin Sealant | Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application. | 96 percentage of patients |
| Manual Compression | Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application. | 88.2 percentage of patients |
Secondary
Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application
Percentage of participants with Hemostasis at the TBS at 3 and 6 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.
Time frame: Intra-operative, 3 and 6 minutes following randomization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bioseal Fibrin Sealant | Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application | Hemostasis at 3 Minutes | 84 percentage of participants |
| Bioseal Fibrin Sealant | Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application | Hemostasis at 6 Minutes | 96.0 percentage of participants |
| Manual Compression | Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application | Hemostasis at 3 Minutes | 43.3 percentage of participants |
| Manual Compression | Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application | Hemostasis at 6 Minutes | 74.0 percentage of participants |
Secondary
Number of Participants Requiring Alternative Treatment Due to Treatment Failure*
Alternative treatments include the use of additional hemostatic methods, including collagen, manual compression, oxidized regenerated cellulose and suture. Manual compression (MC) may be applied after the initial 10 minute observation period as an alternative treatment due to treatment failure in either group. For participants with a treatment failure in MC group, the addition treatment of MC is applied after the initial 10 minute observation period.
Time frame: Intra-operative, 10 minutes following randomization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bioseal Fibrin Sealant | Number of Participants Requiring Alternative Treatment Due to Treatment Failure* | Treated with Collagen | 0 participants |
| Bioseal Fibrin Sealant | Number of Participants Requiring Alternative Treatment Due to Treatment Failure* | Treated with Oxidized Regenerated Cellulose | 2 participants |
| Bioseal Fibrin Sealant | Number of Participants Requiring Alternative Treatment Due to Treatment Failure* | Treated with Manual Compression After 10 Minutes* | 1 participants |
| Bioseal Fibrin Sealant | Number of Participants Requiring Alternative Treatment Due to Treatment Failure* | Treated with Suture | 2 participants |
| Bioseal Fibrin Sealant | Number of Participants Requiring Alternative Treatment Due to Treatment Failure* | Total number requiring alternative treatment | 5 participants |
| Manual Compression | Number of Participants Requiring Alternative Treatment Due to Treatment Failure* | Treated with Suture | 4 participants |
| Manual Compression | Number of Participants Requiring Alternative Treatment Due to Treatment Failure* | Total number requiring alternative treatment | 15 participants |
| Manual Compression | Number of Participants Requiring Alternative Treatment Due to Treatment Failure* | Treated with Collagen | 2 participants |
| Manual Compression | Number of Participants Requiring Alternative Treatment Due to Treatment Failure* | Treated with Manual Compression After 10 Minutes* | 1 participants |
| Manual Compression | Number of Participants Requiring Alternative Treatment Due to Treatment Failure* | Treated with Oxidized Regenerated Cellulose | 8 participants |
Secondary
Percentage of Participants With Potential Bleeding-related Adverse Events
Percentage of participants with potential bleeding-related adverse events by study group
Time frame: 30-days follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bioseal Fibrin Sealant | Percentage of Participants With Potential Bleeding-related Adverse Events | 2.4 percentage of participants |
| Manual Compression | Percentage of Participants With Potential Bleeding-related Adverse Events | 2.4 percentage of participants |