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| Name | Class |
|---|---|
| Guangzhou Bioseal Biotechnology Co., Ltd. | INDUSTRY |
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To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective vascular surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioseal Fibrin Sealant | Experimental | A porcine-derived fibrin sealant consisting of thrombin and fibrinogen |
|
| Manual compression | Other | Manual compresssion (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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioseal Fibrin Sealant | Biological |
| ||
| Manual Compression |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intra-operative, 10 minutes following randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intra-operative, 3 and 6 minutes following randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Kocharian, MD, PhD | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigation Site #21 | Guangzhou | Guangdong | 510080 | China | ||
| Clinical Investigation Site #32 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38695613 | Derived | Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bioseal Fibrin Sealant | A porcine-derived fibrin sealant consisting of thrombin and fibrinogen. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bioseal Fibrin Sealant | A porcine-derived fibrin sealant consisting of thrombin and fibrinogen. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | 95% Confidence Interval | percentage of patients | Intra-operative, 10 minutes following randomization |
|
AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bioseal Fibrin Sealant | A porcine-derived fibrin sealant consisting of thrombin and fibrinogen. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Batiller, Senior Clinical Director | Ethicon, Inc | +1 908 218-2492 | JBatill2@its.jnj.com |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Other |
|
| 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. |
| Intra-operative, 10 minutes following randomization |
| Percentage of Participants With Potential Bleeding-related Adverse Events | Percentage of participants with potential bleeding-related adverse events by study group | 30-days follow-up |
| Nanjing |
| Jiangsu |
| 210008 |
| China |
| Clinical Investigation Site #31 | Nanjing | Jiangsu | 210029 | China |
| Clinical Investigation Site #30 | Jinan | Shandong | 250021 | China |
| Clinical Investigation Site #22 | Chengdu | Sichuan | 610041 | China |
| Clinical Investigation Site #26 | Beijing | 100029 | China |
| Clinical Investigation Site #28 | Beijing | 100853 | China |
| Clinical Investigation Site #25 | Shanghai | 2000011 | China |
| Clinical Investigation Site #23 | Shanghai | 200032 | China |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| BMI Group | BMI Categories: Underweight: <18.5 lb/inch^2; Normal: 18.5<=BMI<25; Overweight: 25<=BMI<30 Obese: 30<=BMI<40 Morbidly obese: BMI>=40 | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Height | Median | Full Range | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Weight | Median | Full Range | kg |
|
| Smoking Status | Number | participants |
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Intra-operative, 3 and 6 minutes following randomization |
|
|
|
| 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. | Posted | Number | participants | Intra-operative, 10 minutes following randomization |
|
|
|
| Secondary | Percentage of Participants With Potential Bleeding-related Adverse Events | Percentage of participants with potential bleeding-related adverse events by study group | Posted | Number | 95% Confidence Interval | percentage of participants | 30-days follow-up |
|
|
|
| 13 |
| 125 |
| 15 |
| 125 |
| EG001 | 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. | 11 | 127 | 13 | 127 |
| Cardiac Failure | Cardiac disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Myocardial Rupture | Cardiac disorders | Systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Multi-organ Failure | General disorders | Systematic Assessment |
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| Necrosis | General disorders | Systematic Assessment |
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| Livery Injury | Hepatobiliary disorders | Systematic Assessment |
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| Appendicitis | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Septic Shock | Infections and infestations | Systematic Assessment |
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| Wound Infection | Infections and infestations | Systematic Assessment |
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| Post-procedural Hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Wound Complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Wound Dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
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| Wound Necrosis | Injury, poisoning and procedural complications | Systematic Assessment |
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| Acinetobacter Test Positive | Investigations | Systematic Assessment |
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| Hypovolemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Cerebral Infarction | Nervous system disorders | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Aortic Dissection Rupture | Vascular disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Hepatic Failure | Hepatobiliary disorders | Systematic Assessment |
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| Lung Infection | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Platelet Count Decreased | Investigations | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Treated with Manual Compression After 10 Minutes* |
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| Treated with Oxidized Regenerated Cellulose |
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| Treated with Suture |
|