At a glance
ClinicalIndex Comparison Record- ✓Pediatric subjects aged ≥28 days (≥1 month) to <18 years requiring non-emergent open hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures
- ✓Minimum of 4 subjects must be aged ≥28 days to <1 year
- ✓Presence of appropriate mild or moderate bleeding soft tissue or hepatic parenchyma target bleeding site identified intra-operatively
- ✓Ability to firmly press trial treatment at target bleeding site for 4 minutes after identification
- ✕Known intolerance to blood products or study product components or unwilling to receive blood products
- ✕Female subjects of childbearing age who are pregnant or nursing
- ✕Currently participating or planning to participate in other investigational device or drug study without sponsor approval
- ✕Known current alcohol and/or drug abuser
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating EVARREST® Fibrin Sealant Patch for Controlling Mild to Moderate Bleeding During Surgery. Completed, enrolled 35 participants across 5 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.