Back to resultsThe Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study
Primary Purpose
Hemorrhage, Soft Tissue Bleeding
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
EVICEL® Fibrin Sealant
SURGICEL® Absorbable Hemostat
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhage focused on measuring Fibrin Sealant, Hemostatics, Coagulants
Eligibility Criteria
Inclusion Criteria:
- Paediatric subjects birth to <18 years of age, requiring non-emergent laparoscopic or open (through peritoneum or pleura) abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures. i) The first 36 subjects to be enrolled will be subjects ≥1 years to <18 years of age. ii) The next 4 subjects to be enrolled will be subjects birth to <1years of age.
- The subject and/or subject's parent or legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. If possible, assent must be obtained from paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the paediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the trial), the parent/legal guardian's written informed consent for the subject will be acceptable for the subject to be included in the study; and
- Presence of an appropriate mild or moderate bleeding soft tissue or parenchymal organ Target Bleeding Site identified intra-operatively by the surgeon;
Exclusion Criteria:
- Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
- Female subjects, who are of childbearing age (i.e. adolescent), who are pregnant or nursing;
- Subject is currently participating or, during the study is planned to participate in any other investigational device or drug trial without prior approval from the Sponsor;
- Subjects who are known, current alcohol and/or drug abusers;
- Subjects admitted for trauma surgery;
- Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
- Subjects with Target Bleeding Site in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
- Anastomotic bleeding sites will not be considered for randomization.
Sites / Locations
- Clinical Investigation Site #31
- Clinical Investigation Site #42
- Clinical Investigation Site #40
- Clinical Investigation Site #41
- Clinical Investigation Site #21
- Clinical Investigation Site #22
- Clinical Investigation Site #20
- Clinical Investigation Site #27
- Clinical Investigation Site #23
- Clinical Investigation Site #26
- Clinical Investigation Site #30
- Clinical Investigation Site #25
- Clinical Investigation Site #24
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EVICEL® Fibrin Sealant
SURGICEL® Absorbable Hemostat
Arm Description
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 (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Outcomes
Primary Outcome Measures
Absolute Time to Haemostasis
Absolute time to haemostasis, defined as absolute time when there was no detectable bleeding at the Target Bleeding Site (TBS).
Secondary Outcome Measures
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.
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.
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).
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.
Estimated Blood Loss
Blood loss during surgical procedure (includes but not limited to the target bleeding site)
Blood Transfusion
Participants requiring a blood transfusion
Participants Receiving a Blood Transfusion
Details of blood products received (if any)
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)
Changes in Laboratory Parameters Haematocrit
Change in red blood cell proportion in volume in the blood from baseline to post operative hospital discharge
Changes in Laboratory Parameters Platelet Count and White Cell Count
Laboratory parameter changes from baseline to post operative hospital discharge
Changes in Laboratory Parameters Red Blood Cell Count
Laboratory parameter changes from baseline to post operative hospital discharge
Changes in Laboratory Parameters Mean Corpuscular Haemoglobin
Laboratory parameter changes from baseline to post operative hospital discharge
Changes in Laboratory Parameters Mean Corpuscular Volume
Laboratory parameter changes from baseline to post operative hospital 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)
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)
Changes in Laboratory Parameters International Normalised Ratio
Standardized measurement of the change in blood clotting time from baseline to post operative hospital discharge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02227706
Brief Title
The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study
Official Title
A Prospective, Randomized, Controlled Study Evaluating EVICEL® Fibrin Sealant as an Adjunct to Haemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) Surgery in Paediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
April 17, 2019 (Actual)
Study Completion Date
May 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Soft Tissue Bleeding
Keywords
Fibrin Sealant, Hemostatics, Coagulants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EVICEL® Fibrin Sealant
Arm Type
Experimental
Arm Description
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
Arm Title
SURGICEL® Absorbable Hemostat
Arm Type
Active Comparator
Arm Description
SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Intervention Type
Biological
Intervention Name(s)
EVICEL® Fibrin Sealant
Other Intervention Name(s)
EVICEL, fibrin sealant
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
SURGICEL® Absorbable Hemostat
Other Intervention Name(s)
oxidized regenerated cellulose
Intervention Description
SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Primary Outcome Measure Information:
Title
Absolute Time to Haemostasis
Description
Absolute time to haemostasis, defined as absolute time when there was no detectable bleeding at the Target Bleeding Site (TBS).
Time Frame
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])
Secondary Outcome Measure Information:
Title
Number of Participants Achieving Haemostasis at 4 Minutes
Description
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.
Time Frame
Intra-operatively from randomisation to 4 minutes after randomisation
Title
Number of Participants Achieving Haemostasis at 7 Minutes
Description
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.
Time Frame
Intra-operatively from randomisation to 7 minutes after randomisation
Title
Number of Participants Achieving Haemostasis at 10 Minutes
Description
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).
Time Frame
Intra-operatively from randomisation to 10 minutes after randomisation
Title
Incidence of Treatment Failures (Number of Participants)
Description
Defined as haemostasis not achieved within 10 minutes or bleeding requiring treatment other than re-application of the assigned haemostatic adjunct within 10 minutes.
Time Frame
10 minutes
Title
Estimated Blood Loss
Description
Blood loss during surgical procedure (includes but not limited to the target bleeding site)
Time Frame
During surgical procedure (first incision to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])
Title
Blood Transfusion
Description
Participants requiring a blood transfusion
Time Frame
From surgical procedure to 30 day (+/-14 day) follow-up visit
Title
Participants Receiving a Blood Transfusion
Description
Details of blood products received (if any)
Time Frame
From surgery to 30 day (+/-14 day) follow-up visit
Title
Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration
Description
Laboratory parameter changes from baseline to post operative hospital discharge (Haemoglobin and Mean Corpuscular Haemoglobin Concentration)
Time Frame
Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Title
Changes in Laboratory Parameters Haematocrit
Description
Change in red blood cell proportion in volume in the blood from baseline to post operative hospital discharge
Time Frame
Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Title
Changes in Laboratory Parameters Platelet Count and White Cell Count
Description
Laboratory parameter changes from baseline to post operative hospital discharge
Time Frame
Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours)
Title
Changes in Laboratory Parameters Red Blood Cell Count
Description
Laboratory parameter changes from baseline to post operative hospital discharge
Time Frame
Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Title
Changes in Laboratory Parameters Mean Corpuscular Haemoglobin
Description
Laboratory parameter changes from baseline to post operative hospital discharge
Time Frame
Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Title
Changes in Laboratory Parameters Mean Corpuscular Volume
Description
Laboratory parameter changes from baseline to post operative hospital discharge
Time Frame
Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Title
Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Description
Laboratory parameter changes in volume from baseline to post operative hospital discharge (Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils)
Time Frame
Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Title
Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time
Description
Laboratory parameter changes from baseline to post operative hospital discharge (Activated Partial Thromboplastin Time and Prothrombin Time)
Time Frame
Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Title
Changes in Laboratory Parameters International Normalised Ratio
Description
Standardized measurement of the change in blood clotting time from baseline to post operative hospital discharge
Time Frame
Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Other Pre-specified Outcome Measures:
Title
Number of Participants With a Thrombotic Event
Description
Number of Participants with a Thrombotic Event.
Time Frame
From randomisation up to 30 days (+/- 14 days) following surgery
Title
Number of Participants With an Adverse Event Related to Re-bleeding at Target Bleeding Site
Description
Number of Participants with an Adverse Event Related to Re-bleeding at Target Bleeding Site.
Time Frame
From randomisation to 30 days (+/- 14 days) following surgery
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Paediatric subjects birth to <18 years of age, requiring non-emergent laparoscopic or open (through peritoneum or pleura) abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures. i) The first 36 subjects to be enrolled will be subjects ≥1 years to <18 years of age. ii) The next 4 subjects to be enrolled will be subjects birth to <1years of age.
The subject and/or subject's parent or legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. If possible, assent must be obtained from paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the paediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the trial), the parent/legal guardian's written informed consent for the subject will be acceptable for the subject to be included in the study; and
Presence of an appropriate mild or moderate bleeding soft tissue or parenchymal organ Target Bleeding Site identified intra-operatively by the surgeon;
Exclusion Criteria:
Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
Female subjects, who are of childbearing age (i.e. adolescent), who are pregnant or nursing;
Subject is currently participating or, during the study is planned to participate in any other investigational device or drug trial without prior approval from the Sponsor;
Subjects who are known, current alcohol and/or drug abusers;
Subjects admitted for trauma surgery;
Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
Subjects with Target Bleeding Site in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
Anastomotic bleeding sites will not be considered for randomization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Kocharian, MD, PhD
Organizational Affiliation
Ethicon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Investigation Site #31
City
Brussels
Country
Belgium
Facility Name
Clinical Investigation Site #42
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Clinical Investigation Site #40
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Clinical Investigation Site #41
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Clinical Investigation Site #21
City
Birmingham
Country
United Kingdom
Facility Name
Clinical Investigation Site #22
City
Leeds
Country
United Kingdom
Facility Name
Clinical Investigation Site #20
City
Liverpool
Country
United Kingdom
Facility Name
Clinical Investigation Site #27
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Clinical Investigation Site #23
City
London
Country
United Kingdom
Facility Name
Clinical Investigation Site #26
City
London
Country
United Kingdom
Facility Name
Clinical Investigation Site #30
City
Newcastle
Country
United Kingdom
Facility Name
Clinical Investigation Site #25
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Clinical Investigation Site #24
City
Southampton
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study
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