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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003464-31 | EudraCT Number |
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The objective of this study is to evaluate the safety and effectiveness of the EVARRESTâ„¢ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVARRESTâ„¢ Fibrin Sealant Patch | Experimental | EVARRESTâ„¢ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). |
|
| Topical hemostat | Active Comparator | Equine collagen with Human Fibrinogen and Human Thrombin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVARRESTâ„¢ Fibrin Sealant Patch | Biological |
| ||
| Topical hemostat |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. | Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure | Intraoperative, 3 minutes following treatment application |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application | The number of subjects achieving hemostatic success at 6 minutes following treatment application with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure. | Intraoperative, 6 minutes following treatment application |
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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 #15 | Atlanta | Georgia | 30342 | United States | ||
| Clinical Investigation Site #14 |
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One subject was randomized to EVARREST, but instead received TachoSil; and analyzed in EVARREST ITT set and in TachoSil group for Safety set. Therefore, Safety set consists of 75 subjects in EVARREST arm and 81 subjects in TachoSil arm, while the ITT set consists of 76 subjects in EVARREST arm and 80 subjects in TachoSil arm.
Subjects were recruited from January 13, 2014 through September 23, 2015 at hospitals and medical centers throughout the United States, United Kingdom, Belgium, Japan and Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | EVARREST Fibrin Sealant Patch | EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin. |
| FG001 | TachoSil |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Biological |
|
| Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application | The number of subjects achieving hemostatic success at 10 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure. | Intraoperative, 10 minutes following treatment application |
| Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment | The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had intra-operative re-bleeding requiring treatment at the TBS | Intra-operative, prior initiation of final chest wall closure. |
| Indianapolis |
| Indiana |
| 46290 |
| United States |
| Clinical Investigation Site #16 | Baltimore | Maryland | 21201 | United States |
| Clinical Investigation Site #21 | Bethesda | Maryland | 20814 | United States |
| Clinical Investigation Site #17 | St Louis | Missouri | 63110 | United States |
| Clinical Investigation Site #10 | Paterson | New Jersey | 07503 | United States |
| Clinical Investigation Site #12 | New York | New York | 10016 | United States |
| Clinical Investigation Site #20 | Philadelphia | Pennsylvania | 19102 | United States |
| Clinical Investigation Site #18 | Houston | Texas | 77030 | United States |
| Clinical Investigation Site #72 | Camperdown | New South Wales | 2050 | Australia |
| Clinical Investigation Site #73 | Sydney | New South Wales | 2010 | Australia |
| Clinical Investigation Site #71 | Brisbane | Queensland | 4000 | Australia |
| Clinical Investigation Site #74 | Bedford Park | South Australia | 5042 | Australia |
| Clinical Investigation Site #70 | Melbourne | Victoria | 3050 | Australia |
| Clinical Investigation Site #40 | Ghent | 9000 | Belgium |
| Clinical Investigation Site #82 | Kanagawa | Isehara-shi | Japan |
| Clinical Investigation Site #81 | Saitama | Saitama-shi | Japan |
| Clinical Investigation Site #80 | Osaka | Suita-shi | Japan |
| Clinical Investigation Site #33 | Bristol | England | BS2 8HW | United Kingdom |
| Clinical Investigation Site #35 | Cottingham | England | HU16 5JQ | United Kingdom |
| Clinical Investigation Site #34 | Manchester | England | M13 9WL | United Kingdom |
| Clinical Investigation Site #32 | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
| Clinical Investigation Site #31 | Clydebank | Scotland | G81 4DY | United Kingdom |
| Clinical Investigation Site #30 | Edinburgh | Scotland | EH16 4SA | United Kingdom |
TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge. |
| Intent to Treat (Randomized Subjects) |
|
| COMPLETED |
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| NOT COMPLETED |
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|
Baseline data was summarized for the Safety Analysis Set, which consists of all subjects on whom the procedure was started.
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| ID | Title | Description |
|---|---|---|
| BG000 | EVARREST Fibrin Sealant Patch | EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin. |
| BG001 | TachoSil | TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| |||||||||||||||||||
| BMI Category | Number | Participants |
|
| 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 | Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. | Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure | The primary endpoint analysis was based on the Intent to Treat (ITT) analysis set, consisting of all randomized subjects. | Posted | Number | Participants | Intraoperative, 3 minutes following treatment application |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application | The number of subjects achieving hemostatic success at 6 minutes following treatment application with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure. | The secondary endpoint analyses were based on the Intent to Treat (ITT) analysis set. | Posted | Number | Participants | Intraoperative, 6 minutes following treatment application |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application | The number of subjects achieving hemostatic success at 10 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure. | Posted | Number | Participants | Intraoperative, 10 minutes following treatment application |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment | The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had intra-operative re-bleeding requiring treatment at the TBS | Posted | Number | Participants | Intra-operative, prior initiation of final chest wall closure. |
|
|
From surgical procedure through the 60 day follow-up (+/-14 days)
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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 | EVARREST Fibrin Sealant Patch | EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin. | 31 | 75 | 73 | 75 | ||
| EG001 | TachoSil | TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge. | 34 | 81 | 80 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA version 15 | Systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | MedDRA version 15 | Systematic Assessment |
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| Haemolytic Anaemia | Blood and lymphatic system disorders | MedDRA version 15 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 15 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 15 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 15 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA version 15 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA version 15 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA version 15 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA version 15 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA version 15 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA version 15 | Systematic Assessment |
| |
| Myocardial depression | Cardiac disorders | MedDRA version 15 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA version 15 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA version 15 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA version 15 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 15 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA version 15 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 15 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA version 15 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 15 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA version 15 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA version 15 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 15 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA version 15 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA version 15 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 15 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA version 15 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA version 15 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA version 15 | Systematic Assessment |
| |
| Anastomotic haemorrhage | Injury, poisoning and procedural complications | MedDRA version 15 | Systematic Assessment |
| |
| Arterial injury | Injury, poisoning and procedural complications | MedDRA version 15 | Systematic Assessment |
| |
| Cardiac procedure complication | Injury, poisoning and procedural complications | MedDRA version 15 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 15 | Systematic Assessment |
| |
| Postoperative thoracic procedure complication | Injury, poisoning and procedural complications | MedDRA version 15 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA version 15 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 15 | Systematic Assessment |
| |
| Anticoagulation drug level above therapeutic | Investigations | MedDRA version 15 | Systematic Assessment |
| |
| International normalised ratio fluctuation | Investigations | MedDRA version 15 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 15 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 15 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 15 | Systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA version 15 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 15 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA version 15 | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA version 15 | Systematic Assessment |
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| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA version 15 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA version 15 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA version 15 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA version 15 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA version 15 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA version 15 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 15 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA version 15 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA version 15 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 15 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 15 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 15 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA version 15 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA version 15 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA version 15 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 15 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 15 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA version 15 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 15 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 15 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 15 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA version 15 | Systematic Assessment |
| |
| Anastomotic haemorrhage | Injury, poisoning and procedural complications | MedDRA version 15 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 15 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 15 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA version 15 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA version 15 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 15 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 15 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 15 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 15 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 15 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 15 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA version 15 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 15 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 15 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA version 15 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA version 15 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA version 15 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 15 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 15 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 15 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA version 15 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Kocharian, MD, PhD | Ethicon, Inc. | 1 (908) 218-2013 | rkochar1@ITS.JNJ.com |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Title | Measurements |
|---|---|
|
| 50 < 65 years |
|
| 65 < 75 |
|
| >= 75 |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| Asian |
|
| Other |
|
| Normal |
|
| Overweight |
|
| Obese |
|
| Morbidly obese |
|
|
|
|
|