The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study (NCT03255174) | Clinical Trial Compass
CompletedPhase 3
The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
United States, United Kingdom35 participantsStarted 2018-03-20
Plain-language 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.
Who can participate
Age range28 Days – 17 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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.
✓. Presence of an appropriate mild or moderate bleeding soft tissue or hepatic parenchyma Target Bleeding Site (TBS) identified intra-operatively by the surgeon;
✓. Ability to firmly press trial treatment at TBS until 4 minutes after TBS identification.
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, of childbearing age (i.e. adolescent), who are pregnant or nursing;
✕. Subject is currently participating or plan to participate in any other investigational device or drug study without prior approval from the Sponsor;
✕. Subjects who are known, current alcohol and/or drug abusers
What they're measuring
1
Absolute Time to Hemostasis
Timeframe: During surgical procedure on Day 0 (from TBS identification to the last moment in time at which detectable bleeding at TBS observed)
✕. Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
✕. 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
✕. Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)