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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003401-26 | EudraCT Number |
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To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.
This is a prospective, randomized, controlled, clinical study comparing EVICEL® to SURGICEL®, as an adjunct to haemostasis when conventional methods of controlling bleeding are ineffective or impractical during surgery in paediatric patients.
At least 40 qualified paediatric subjects with an appropriate mild or moderate Target Bleeding Site (TBS) will be randomized in a 1:1 allocation ratio to either EVICEL® or SURGICEL®. Haemostasis will be assessed at 4, 7 and 10 minutes from randomization.
Enrolment will be staggered by age (as required by the European Medicines Agency (EMA) Paediatric Committee). The first group enrolled will include at least 36 subjects aged ≥1 years to <18 years of age. When enrolment of the first group is complete; enrolment of a subsequent group will commence and include at least 4 subjects from birth (including neonates ≤37 weeks gestation) to <1 years of age.
Subjects will be followed post-operatively through hospital discharge and at 30 days (±14 days) post-surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVICEL® Fibrin Sealant | Experimental | EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product |
|
| SURGICEL® Absorbable Hemostat | Active Comparator | SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVICEL® Fibrin Sealant | Biological | EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Time to Haemostasis | Absolute time to haemostasis, defined as absolute time when there was no detectable bleeding at the Target Bleeding Site (TBS). | From randomisation (identification of appropriate target bleeding site) to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes]) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Haemostasis at 4 Minutes | Number of participants achieving haemostasis at target bleeding site at 4 minutes. This endpoint is assessing haemostasis at 4 minutes only and not maintenance of haemostasis following this timepoint. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis. | Intra-operatively from randomisation to 4 minutes after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Thrombotic Event | Number of Participants with a Thrombotic Event. | From randomisation up to 30 days (+/- 14 days) following surgery |
| Number of Participants With an Adverse Event Related to Re-bleeding at Target Bleeding Site |
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 #31 | Brussels | Belgium | ||||
| Clinical Investigation Site #42 |
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Subjects required to meet pre-defined inclusion/exclusion criteria prior to randomization. Subjects required to have an appropriate mild or moderate target bleeding site identified intra-operatively.
Subjects were excluded if the target bleeding site was in an actively infected field or if the bleeding was at an anastomotic bleeding site.
Subjects were screened up to 21 days prior to surgery and attended a baseline visit within 24 hours of surgery. Both visits took place at a clinic within the hospital where surgery also took place. Subjects were followed until discharge and requested to attend a visit at 30 days (+/- 14 days) post surgery either at the hospital or via telephone.
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| ID | Title | Description |
|---|---|---|
| FG000 | EVICEL® | EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin. |
| FG001 | SURGICEL® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 8, 2018 | Apr 10, 2020 |
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| SURGICEL® Absorbable Hemostat | Device | SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. |
|
|
| Number of Participants Achieving Haemostasis at 7 Minutes | Number of Participants Achieving Haemostasis at Target Bleeding Site at 7 Minutes. This endpoint is assessing haemostasis at 7 minutes only and is not affected by haemostasis assessment prior to 7 minutes or maintenance of haemostasis following this 7 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis. | Intra-operatively from randomisation to 7 minutes after randomisation |
| Number of Participants Achieving Haemostasis at 10 Minutes | Number of Participants Achieving Haemostasis at Target Bleeding Site at 10 Minutes. This endpoint is assessing haemostasis at 10 minutes only and is not affected by haemostasis assessments prior to 10 minutes or maintenance of haemostasis following this 10 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis). | Intra-operatively from randomisation to 10 minutes after randomisation |
| Incidence of Treatment Failures (Number of Participants) | Defined as haemostasis not achieved within 10 minutes or bleeding requiring treatment other than re-application of the assigned haemostatic adjunct within 10 minutes. | 10 minutes |
| Estimated Blood Loss | Blood loss during surgical procedure (includes but not limited to the target bleeding site) | During surgical procedure (first incision to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes]) |
| Blood Transfusion | Participants requiring a blood transfusion | From surgical procedure to 30 day (+/-14 day) follow-up visit |
| Participants Receiving a Blood Transfusion | Details of blood products received (if any) | From surgery to 30 day (+/-14 day) follow-up visit |
| Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration | Laboratory parameter changes from baseline to post operative hospital discharge (Haemoglobin and Mean Corpuscular Haemoglobin Concentration) | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) |
| Changes in Laboratory Parameters Haematocrit | Change in red blood cell proportion in volume in the blood from baseline to post operative hospital discharge | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) |
| Changes in Laboratory Parameters Platelet Count and White Cell Count | Laboratory parameter changes from baseline to post operative hospital discharge | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours) |
| Changes in Laboratory Parameters Red Blood Cell Count | Laboratory parameter changes from baseline to post operative hospital discharge | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) |
| Changes in Laboratory Parameters Mean Corpuscular Haemoglobin | Laboratory parameter changes from baseline to post operative hospital discharge | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) |
| Changes in Laboratory Parameters Mean Corpuscular Volume | Laboratory parameter changes from baseline to post operative hospital discharge | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) |
| Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Laboratory parameter changes in volume from baseline to post operative hospital discharge (Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils) | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) |
| Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time | Laboratory parameter changes from baseline to post operative hospital discharge (Activated Partial Thromboplastin Time and Prothrombin Time) | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) |
| Changes in Laboratory Parameters International Normalised Ratio | Standardized measurement of the change in blood clotting time from baseline to post operative hospital discharge | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) |
Number of Participants with an Adverse Event Related to Re-bleeding at Target Bleeding Site.
| From randomisation to 30 days (+/- 14 days) following surgery |
| Hamilton |
| Ontario |
| Canada |
| Clinical Investigation Site #40 | Toronto | Ontario | Canada |
| Clinical Investigation Site #41 | Montreal | Quebec | Canada |
| Clinical Investigation Site #21 | Birmingham | United Kingdom |
| Clinical Investigation Site #22 | Leeds | United Kingdom |
| Clinical Investigation Site #20 | Liverpool | United Kingdom |
| Clinical Investigation Site #27 | London | SE1 7EH | United Kingdom |
| Clinical Investigation Site #23 | London | United Kingdom |
| Clinical Investigation Site #26 | London | United Kingdom |
| Clinical Investigation Site #30 | Newcastle | United Kingdom |
| Clinical Investigation Site #25 | Nottingham | NG7 2UH | United Kingdom |
| Clinical Investigation Site #24 | Southampton | United Kingdom |
SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | EVICEL® | EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin. |
| BG001 | SURGICEL® | SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose. |
| 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, Continuous | Mean | Full Range | Years |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| 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 | Absolute Time to Haemostasis | Absolute time to haemostasis, defined as absolute time when there was no detectable bleeding at the Target Bleeding Site (TBS). | Full Analysis Set (all randomized subjects) | Posted | Median | 95% Confidence Interval | Minutes | From randomisation (identification of appropriate target bleeding site) to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes]) |
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| Secondary | Number of Participants Achieving Haemostasis at 4 Minutes | Number of participants achieving haemostasis at target bleeding site at 4 minutes. This endpoint is assessing haemostasis at 4 minutes only and not maintenance of haemostasis following this timepoint. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis. | Full Analysis Set (all randomized subjects) | Posted | Count of Participants | Participants | Intra-operatively from randomisation to 4 minutes after randomisation |
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| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving Haemostasis at 7 Minutes | Number of Participants Achieving Haemostasis at Target Bleeding Site at 7 Minutes. This endpoint is assessing haemostasis at 7 minutes only and is not affected by haemostasis assessment prior to 7 minutes or maintenance of haemostasis following this 7 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis. | Full Analysis Set (all randomized subjects) | Posted | Count of Participants | Participants | Intra-operatively from randomisation to 7 minutes after randomisation |
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| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving Haemostasis at 10 Minutes | Number of Participants Achieving Haemostasis at Target Bleeding Site at 10 Minutes. This endpoint is assessing haemostasis at 10 minutes only and is not affected by haemostasis assessments prior to 10 minutes or maintenance of haemostasis following this 10 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis). | Full Analysis Set (all randomized subjects) | Posted | Count of Participants | Participants | Intra-operatively from randomisation to 10 minutes after randomisation |
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| Secondary | Incidence of Treatment Failures (Number of Participants) | Defined as haemostasis not achieved within 10 minutes or bleeding requiring treatment other than re-application of the assigned haemostatic adjunct within 10 minutes. | Full Analysis Set (all randomized subjects) Note: Two subjects in the control arm were haemostatic at the TBS at 10 minutes however they subsequently rebled requiring additional treatment and were conservatively considered a failure for the secondary endpoint of Incidence of Treatment Failures. | Posted | Count of Participants | Participants | 10 minutes |
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| Secondary | Estimated Blood Loss | Blood loss during surgical procedure (includes but not limited to the target bleeding site) | Full Analysis Set (all randomized subjects) | Posted | Median | Full Range | mL | During surgical procedure (first incision to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes]) |
|
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| Secondary | Blood Transfusion | Participants requiring a blood transfusion | Full Analysis Set (all randomized subjects) | Posted | Count of Participants | Participants | From surgical procedure to 30 day (+/-14 day) follow-up visit |
|
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| Secondary | Participants Receiving a Blood Transfusion | Details of blood products received (if any) | Full Analysis Set (all randomized subjects with data) | Posted | Count of Participants | Participants | From surgery to 30 day (+/-14 day) follow-up visit |
|
| ||||||||||||||||||||||||||||||
| Secondary | Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration | Laboratory parameter changes from baseline to post operative hospital discharge (Haemoglobin and Mean Corpuscular Haemoglobin Concentration) | Safety Set (all subjects who received treatment) | Posted | Mean | Standard Deviation | g/L | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) |
|
| |||||||||||||||||||||||||||||
| Secondary | Changes in Laboratory Parameters Haematocrit | Change in red blood cell proportion in volume in the blood from baseline to post operative hospital discharge | Safety Set (all subjects who received treatment) | Posted | Mean | Standard Deviation | L/L | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) |
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| Secondary | Changes in Laboratory Parameters Platelet Count and White Cell Count | Laboratory parameter changes from baseline to post operative hospital discharge | Safety Set (all subjects who received treatment) | Posted | Mean | Standard Deviation | Cells*10^9/L | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours) |
|
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| Secondary | Changes in Laboratory Parameters Red Blood Cell Count | Laboratory parameter changes from baseline to post operative hospital discharge | Safety Set (all subjects who received treatment) | Posted | Mean | Standard Deviation | Cells*10^12/L | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) |
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| Secondary | Changes in Laboratory Parameters Mean Corpuscular Haemoglobin | Laboratory parameter changes from baseline to post operative hospital discharge | Safety Set (all subjects who received treatment) | Posted | Mean | Standard Deviation | pg | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) |
|
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| Secondary | Changes in Laboratory Parameters Mean Corpuscular Volume | Laboratory parameter changes from baseline to post operative hospital discharge | Safety Set (all subjects who received treatment) | Posted | Mean | Standard Deviation | f/L | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) |
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| Secondary | Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils | Laboratory parameter changes in volume from baseline to post operative hospital discharge (Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils) | Safety Set (all subjects who received treatment) | Posted | Mean | Standard Deviation | Percent Volume | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) |
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| Secondary | Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time | Laboratory parameter changes from baseline to post operative hospital discharge (Activated Partial Thromboplastin Time and Prothrombin Time) | Safety Set (all subjects who received treatment) | Posted | Mean | Standard Deviation | Seconds | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) |
|
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| Secondary | Changes in Laboratory Parameters International Normalised Ratio | Standardized measurement of the change in blood clotting time from baseline to post operative hospital discharge | Safety Set (all subjects who received treatment) | Posted | Mean | Standard Deviation | Ratio | Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge) |
|
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| Other Pre-specified | Number of Participants With a Thrombotic Event | Number of Participants with a Thrombotic Event. | Safety Set (all subjects who received treatment) | Posted | Count of Participants | Participants | From randomisation up to 30 days (+/- 14 days) following surgery |
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| Other Pre-specified | Number of Participants With an Adverse Event Related to Re-bleeding at Target Bleeding Site | Number of Participants with an Adverse Event Related to Re-bleeding at Target Bleeding Site. | Safety Set (all subjects who received treatment) | Posted | Count of Participants | Participants | From randomisation to 30 days (+/- 14 days) following surgery |
|
|
Adverse Events were collected from point of randomisation, during the procedure, throughout hospital admission and until completion of the 30 day (+/-14 day) follow up visit.
Additional adverse event collection information:
Since post operative pain is an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post operative pain based on the Investigator's judgment were reported as an AE.
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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 | EVICEL® | EVICEL® is a human plasma derived fibrin sealant consisting of two components: (1) Biologically Active Component 2 (BAC2), a concentrate of human clottable protein (containing mainly human fibrinogen and fribrinectin), and (2) human thrombin. | 0 | 20 | 4 | 20 | 18 | 20 |
| EG001 | SURGICEL® | SURGICEL® Absorbable hemostat is a sterile absorbable knitted fabric prepared by controlled oxidation of regenerated cellulose. | 0 | 20 | 3 | 20 | 20 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Varicella | Infections and infestations | MedDRA 16.0 | Systematic Assessment | Chicken Pox |
|
| Brain Injury | Nervous system disorders | MedDRA 16.0 | Systematic Assessment | Hypoxic Brain Injury |
|
| Clostridium difficile infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Ureteral stent removal | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Castleman's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Mucous stools | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Teething | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Device occlusion | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Orchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Post procedural infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Procedural complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Respiratory rate decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Respiratory rate increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Urine output decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Hyponatraemic syndrome | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Polydipsia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neonatal aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Livedo reticularis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Wound drainage | Surgical and medical procedures | MedDRA 16.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
Any publication based on the results obtained at the trial site (or group of sites) shall not be made before the first multi-centre publication.
During the review period of a proposed publication, the Sponsor is entitled to request that publication be delayed for a period of up to six months from the date of first submission to the Sponsor to enable the Sponsor to take steps to protect its proprietary information and/or Intellectual Property Rights and Know How.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Schleckser | ETHICON Inc | 9082182244 | pschleck@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2019 | Apr 10, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Infants and toddlers (31 days-<24 months) |
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| Children (2-11 years) |
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| Adolescents (12-17 years) |
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| Male |
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| Asian |
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| Other |
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