The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
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|ClinicalTrials.gov Identifier: NCT02227992|
Recruitment Status : Recruiting
First Posted : August 28, 2014
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhage Soft Tissue Bleeding Hepatic Parenchyma Bleeding||Biological: EVARREST™ Sealant Matrix Device: SURGICEL®||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized, Controlled, Study Evaluating the Safety and Effectiveness of EVARREST® Sealant Matrix in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic and Thoracic (Non-cardiac) Surgery in Paediatric Patients|
|Actual Study Start Date :||July 1, 2014|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||January 1, 2020|
Experimental: EVARREST™ Sealant Matrix
EVARREST™ Sealant Matrix/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).
Biological: EVARREST™ Sealant Matrix
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.
Other Name: EVARREST™ Fibrin Sealant Patch
Active Comparator: SURGICEL® Absorbable Hemostat
SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
SURGICEL® Absorbable Hemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Other Name: oxidized regenerated cellulose
- Absolute time to haemostasis [ Time Frame: intraoperative ]
- Proportion of subjects achieving haemostatic success at 4 minutes following randomization [ Time Frame: intraoperative ]
- Proportion of subjects achieving haemostatic success at 10 minutes following randomization [ Time Frame: intraoperative ]
- Portion of subjects with no re-bleeding at the TBS [ Time Frame: intraoperative ]
- Incidence of adverse events that are potentially related to bleeding at the target bleeding site (TBS) [ Time Frame: Through 30-day follow-up ]
- Incidence of adverse events that are potentially related to thrombotic events [ Time Frame: Through the 30-day follow-up ]
- Incidence of re-treatment at the TBS [ Time Frame: Intraoperative ]
- Incidence of adverse events [ Time Frame: Through the 30-day follow-up ]
- Summarization of Haemoglobin [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
- Summarization of Haematocrit [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
- Summarization of Platelets laboratory results [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
- Summarization of volume of blood loss [ Time Frame: Intraoperative ]
- Sumamry of volume of blood and blood products transfusions [ Time Frame: Intra-operative through 30-day follow-up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227992
|Contact: Leonie Rynn, MD||908-218-2492||LRynn1@its.jnj.com|
|Clinical Investigation Site #32||Recruiting|
|Brussels, Belgium, 1020|
|Clinical Investigation Site #31||Recruiting|
|Clinical Investigation Site #21||Recruiting|
|Birmingham, United Kingdom|
|Clinical Investigation Site #22||Recruiting|
|Leeds, United Kingdom|
|Clinical Investigation Site #20||Recruiting|
|Liverpool, United Kingdom|
|Clinical Investigation Site #26||Recruiting|
|London, United Kingdom, SE1 7EH|
|Clinical Investigation Site #23||Completed|
|London, United Kingdom|
|Clinical Investigation Site #25||Recruiting|
|Nottingham, United Kingdom, NG7 2UH|
|Clinical Investigation Site #24||Recruiting|
|Southampton, United Kingdom, SO16 6YD|
|Study Director:||Richard Kocharian, MD, PhD||Ethicon, Inc.|