Clinical trial NCT03255174: The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
Official title: A Prospective Study Evaluating the Safety and Effectiveness of EVARREST® Fibrin Sealant Patch in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic and Thoracic (Non-cardiac) Surgery in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Controlling Mild to Moderate Bleeding During Surgery
Keywords: Bleeding, hemostasis, re-bleeding, hemostatic
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-21
Enrollment: 35
Sex: ALL
Minimum age (years): 28
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in pediatric population.

Detailed description: This is an open-label, multicenter, single-arm study evaluating the safety and effectiveness of EVARREST in controlling mild or moderate bleeding in hepatic parenchyma or soft tissue for which standard methods of achieving hemostasis are ineffective or impractical.

Eligible subjects will be treated with EVARREST. Subjects will be followed post-operatively through discharge and at 30 days (+/-14 days) post-surgery.

At least thirty-five pediatric subjects with an appropriate mild or moderate bleeding target bleeding site (TBS) will be enrolled in this study. The age of the subjects enrolled in the study will be from 1 month to less than (\<) 18 years. This will include a minimum of 4 subjects aged 1 month (greater than or equal to \[\>=\] 28 days from birth) to \<1 year.

Eligibility criteria: Inclusion Criteria:

1. Pediatric subjects aged ≥28 days (≥1 month) to \<18 years, requiring non-emergent open hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures; i) A minimum of 4 subjects to be enrolled will be aged ≥28 days to \<1 year
2. The subject's parent/legal guardian must be willing to give permission for the subject to participate in the trial, and provide written Informed Consent for the subject. In addition, assent must be obtained from pediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the pediatric 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.
3. Presence of an appropriate mild or moderate bleeding soft tissue or hepatic parenchyma Target Bleeding Site (TBS) identified intra-operatively by the surgeon;
4. Ability to firmly press trial treatment at TBS until 4 minutes after TBS identification.

Exclusion Criteria:

1. Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
2. Female subjects, of childbearing age (i.e. adolescent), who are pregnant or nursing;
3. Subject is currently participating or plan to participate in any other investigational device or drug study without prior approval from the Sponsor;
4. Subjects who are known, current alcohol and/or drug abusers
5. Subjects admitted for trauma surgery
6. Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
7. Subjects that have received a COVID-19 vaccine either 4 weeks prior to surgery or scheduled to receive COVID-19 vaccine within the 30-day follow-up period
8. Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
9. TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST to blood flow and pressure during healing and absorption of the product
10. TBS with major arterial bleeding requiring suture or mechanical ligation;
11. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.

Primary outcomes:
measure: Absolute time to hemostasis
timeFrame: Intraoperative from TBS identification to the last moment in time at which no detectable bleeding at the TBS is observed
Secondary outcomes:
measure: Hemostatic success at 4 minutes
timeFrame: Intraoperative, 4 minutes after TBS identification
measure: Hemostatic success at 10 minutes
timeFrame: Intraoperative, 10 minutes after TBS identification
measure: No re-bleeding at the TBS
timeFrame: Intraoperative, from TBS identification to final fascial closure
measure: Incidence of adverse events that are potentially related to bleeding at the TBS
timeFrame: Intraoperative to 30 (+/- 14) days
measure: Incidence of adverse events that are potentially related to thrombotic events
timeFrame: Intraoperative to 30 (+/- 14) days
measure: Incidence of re-treatment at the TBS
timeFrame: Intraoperative, from TBS identification to final fascial closure
measure: Incidence of Adverse Events
timeFrame: Intraoperative to 30 (+/- 14) days
measure: Number of Participants with Abnormalities in Clinical Laboratory Tests
timeFrame: Intraoperative to 30 days
measure: Number of Participants with Estimated Intraoperative Blood Loss
timeFrame: Intraoperative to 30 days
measure: Number of Participants with Blood products Transfused
timeFrame: Intraoperative to 30 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital
state: Alabama
city: New York
country: United States
facility: icahn School of Medicine at Mt Sinai
state: New York
city: Birmingham
country: United Kingdom
facility: Birmingham Chrildren's Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
References: