The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue \& parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in paediatric patients.
This is an open label, prospective, randomised, multicentre, controlled, clinical study comparing EVARREST to SURGICEL (oxidized regenerated cellulose (ORC)) (Control) as an adjunct to haemostasis when conventional methods of controlling mild or moderate bleeding are ineffective or impractical during surgery in paediatric patients. At least 40 qualified paediatric subjects with an appropriate mild or moderate bleeding Target Bleeding Site (TBS) will be randomised in a 1:1 allocation ratio to either EVARREST or SURGICEL (control). Absolute time to haemostasis will be assessed as well as haemostasis at 4 and 10 minutes from randomisation. Enrolment will be staggered by age (as required by the European Medicines Agency (EMA) Paediatric Committee). The first 36 subjects enrolled will be aged ≥1 years to \<18 years of age. Enrolment of a subsequent group will include 4 subjects from 1 month (≥ 28 days from birth) to \<1 year of age will follow. Ongoing safety assessment will ensure adequate safety monitoring occur during the staged enrolment. Subjects will be followed post-operatively through hospital discharge and at 30 days (+/-14 days) post-surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
EVARREST® Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.
SURGICEL® Absorbable Hemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Clinical Investigation Site #32
Brussels, Belgium
Investigative Site #30
Genk, Belgium
Clinical Investigation Site #31
Ghent, Belgium
Clinical Investigation Site #21
Absolute Time to Haemostasis (TTH)
Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the target bleeding site (TBS) was observed.
Time frame: Up to 1 day (Intraoperative)
Absolute Time to Haemostasis (TTH) by Age Group
Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the TBS was observed.
Time frame: Up to 1 day (Intraoperative)
Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure
Percentage of participants achieving haemostatic success at 4 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported.
Time frame: 4 minutes post randomization (up to 1 day; intraoperative)
Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure
Percentage of participants achieving haemostatic success at 10 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported.
Time frame: 10 minutes post randomization (up to 1 day; intraoperative)
Percentage of Participants With No Re-bleeding at the Target Bleeding Site
Percentage of participants with no re-bleeding at the TBS were reported.
Time frame: Up to 44 days post-surgery on Day 0
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Birmingham, United Kingdom
Clinical Investigation Site #22
Leeds, United Kingdom
Clinical Investigation Site #20
Liverpool, United Kingdom
Clinical Investigation Site #26
London, United Kingdom
Clinical Investigation Site #23
London, United Kingdom
Clinical Investigation Site #25
Nottingham, United Kingdom
Clinical Investigation Site #24
Southampton, United Kingdom
Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS
Number of participants With AEs that were potentially related to bleeding at the TBS were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Up to 44 days post-surgery on Day 0
Number of Participants With AEs That Were Potentially Related To Thrombotic Events
Number of participants with AEs that were potentially related to thrombotic events (sponsor assessment) were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Up to 44 days post-surgery on Day 0
Number of Participants Who Required Re-treatment At The Target Bleeding Site
Number of participants who required re-treatment at the TBS were reported.
Time frame: Up to 44 days post-surgery on Day 0
Number of Participants With Adverse Events
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Up to 44 days post-surgery on Day 0
Change From Baseline to Post-surgery in Haemoglobin
Change from baseline to post-surgery in haemoglobin were reported.
Time frame: From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)
Change From Baseline to Post-surgery in Haematocrit
Change from baseline to post-surgery in Haematocrit was reported.
Time frame: From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)
Change From Baseline to Post-surgery in Platelet Count
Change from baseline to post-surgery in platelet count was reported.
Time frame: From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0)
Estimated Volume of Blood Loss
Estimated volume of intra-operative blood loss (including but not limited to the TBS) was reported.
Time frame: Up to 1 day (intraoperative)
Number of Participants Who Received Blood Transfusions
Number of participants who received blood transfusions (red blood cells \[RBCs\], whole blood, fresh frozen plasma, platelets, and cryoprecipitates) were reported.
Time frame: Up to 44 days post-surgery on Day 0