Hemostasis, Meningioma Surgery
Conditions
Brief summary
The objective of this study is to observe the clinical utility and performance of Bioseal when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma surgery.
Interventions
BIOLOGICALBioseal Fibrin Sealant
OTHERStandard of Care (SoC)
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
* Subjects between 18 and 75 years of age * Undergoing elective meningioma surgery and having a tumor cavity * Presence of an appropriate Target Bleeding Site (TBS) as identified intra-operatively by the surgeon requiring an adjunct to achieve hemostasis * Able and willing to comply with procedures required by protocol * Signed and dated written informed consent prior to any study related procedures.
Exclusion criteria
* Subjects undergoing emergency surgery * Subjects with any intra-operative findings that may preclude conducting of the study procedures * Intended use of Fibrin Sealants (including autologous Fibrin Sealants) other than Bioseal on the Target Bleeding Site (TBS) * Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products * Subjects who have a history of traumatic head injury * Female subjects who are known breastfeeding or pregnant or intend to become pregnant during the clinical study period * The subject, in the opinion of the investigator, would not be suitable for participation in the study * 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 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS. | Intra-operative, 6 minutes following randomization | The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 6 minutes following start of treatment application. Hemostasis is defined as no detectable bleeding at the TBS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis at the TBS at 3 Minutes Following Treatment Application | Intra-operative, 3 minutes following randomization | The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 3 minutes following start of treatment application. Hemostasis was defined as no detectable bleeding at the TBS. |
| Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications. | Through 30-day follow-up | — |
| Incidence of Potential Bleeding-related Adverse Events | Through 30-day follow-up | — |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care (SoC) Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH). Standard of Care (SoC) | 129 |
| Bioseal Fibrin Sealant A porcine-derived fibrin sealant consisting of thrombin and fibrinogen Bioseal Fibrin Sealant | 127 |
| Total | 256 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Bioseal Fibrin Sealant | Total | Standard of Care (SoC) |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical >=65 years | 28 Participants | 51 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 98 Participants | 204 Participants | 106 Participants |
| Age, Continuous | 50.7 years STANDARD_DEVIATION 11.7 | 49.8 years STANDARD_DEVIATION 11.5 | 48.9 years STANDARD_DEVIATION 11.3 |
| BMI | 23.1 (kg/m^2) | 22.8 (kg/m^2) | 23.2 (kg/m^2) STANDARD_DEVIATION 3.4 |
| BMI Group Normal | 95 participants | 191 participants | 96 participants |
| BMI Group Obese | 3 participants | 11 participants | 8 participants |
| BMI Group Overweight | 27 participants | 49 participants | 22 participants |
| BMI Group Underweight | 2 participants | 5 participants | 3 participants |
| Height | 161 cm | 162 cm | 164.5 cm STANDARD_DEVIATION 7 |
| Sex: Female, Male Female | 80 Participants | 149 Participants | 69 Participants |
| Sex: Female, Male Male | 47 Participants | 107 Participants | 60 Participants |
| Smoking Status Current Smoker | 12 participants | 30 participants | 18 participants |
| Smoking Status Former Smoker | 3 participants | 7 participants | 4 participants |
| Smoking Status Never Smoked | 112 participants | 219 participants | 107 participants |
| Weight | 62.2 kg STANDARD_DEVIATION 8.8 | 61 kg | 62.9 kg STANDARD_DEVIATION 10.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 129 | 26 / 127 |
| serious Total, serious adverse events | 10 / 129 | 5 / 127 |
Outcome results
Primary
Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS.
The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 6 minutes following start of treatment application. Hemostasis is defined as no detectable bleeding at the TBS.
Time frame: Intra-operative, 6 minutes following randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SoC) | Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS. | 99.2 % of participants |
| Bioseal Fibrin Sealant | Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS. | 100 % of participants |
Comparison: H0: Delta \</= -0.1 HA: Delta \> -0.1 Delta is difference in proportion of successes between Bioseal and SOC gropus (Bioseal minus SOC). Success is defined as hemostasis at the TBS at 6 minutes following treatment application95% CI: [-0.048, 0.199]
Secondary
Hemostasis at the TBS at 3 Minutes Following Treatment Application
The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 3 minutes following start of treatment application. Hemostasis was defined as no detectable bleeding at the TBS.
Time frame: Intra-operative, 3 minutes following randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SoC) | Hemostasis at the TBS at 3 Minutes Following Treatment Application | 89.9 % of participants |
| Bioseal Fibrin Sealant | Hemostasis at the TBS at 3 Minutes Following Treatment Application | 94.5 % of participants |
Secondary
Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.
Time frame: Through 30-day follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care (SoC) | Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications. | Central Nervous System | 6 participants |
| Standard of Care (SoC) | Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications. | Neurosurgical Complication | 14 participants |
| Standard of Care (SoC) | Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications. | Surgical Wound Complication | 5 participants |
| Standard of Care (SoC) | Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications. | Unplanned Intervention | 5 participants |
| Bioseal Fibrin Sealant | Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications. | Surgical Wound Complication | 3 participants |
| Bioseal Fibrin Sealant | Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications. | Neurosurgical Complication | 14 participants |
| Bioseal Fibrin Sealant | Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications. | Central Nervous System | 8 participants |
| Bioseal Fibrin Sealant | Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications. | Unplanned Intervention | 3 participants |
Secondary
Incidence of Potential Bleeding-related Adverse Events
Time frame: Through 30-day follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care (SoC) | Incidence of Potential Bleeding-related Adverse Events | 18 participants |
| Bioseal Fibrin Sealant | Incidence of Potential Bleeding-related Adverse Events | 18 participants |