Mild or moderate hepatic parenchyma or soft tissue bleeding during open, abdominal, retroperitoneal, pelvic and thoracic (non-cardiac) surgery
Conditions
Interventions
Trade Name: EVARREST®
Product Name: EVARREST Fibrin Sealant Patch
Pharmaceutical Form: Sealant matrix
INN or Proposed INN: Human Thrombin
CAS Number: 9002-04-4
Other descriptive name: HUMAN THROMBIN
C
Sponsors
Ethicon Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pre-operative: 1. Pediatric subjects aged =28 days (=1 month) to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pre-Operative: 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. Intra-operative 7. Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected) 8. 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; 9. TBS with major arterial bleeding requiring suture or mechanical ligation; 10. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the safety and haemostatic effectiveness of the EVARREST® Fibrin Sealant Patch in controlling mild or moderate soft tissue and parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in paediatric patients.;Secondary Objective: not applicable;Primary end point(s): Absolute time to hemostasis defined as the absolute time elapsed from TBS (Target Bleeding Site) identification to the last moment in time at which detectable bleeding at the TBS is observed.;Timepoint(s) of evaluation of this end point: Starting from TBS identification to the last moment in time at which detectable bleeding at the TBS is observed | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of subjects achieving haemostatic success at 4 minutes following TBS identification and no bleeding requiring treatment at the TBS occurs any time prior to final fascial closure 2. Proportion of subjects achieving haemostatic success at 10 minutes following TBS identification and no bleeding requiring treatment at the TBS occurs any time prior to final fascial closure 3. Portion of subjects with no re-bleeding at the TBS 4. Incidence of adverse events that are potentially related to bleeding at the TBS 5. Incidence of adverse events that are potentially related to thrombotic events 6. Incidence of re-treatment at the TBS 7. Incidence of adverse events 8. Summarization of Haemoglobin, Haematocrit, Platelets laboratory results, volume of blood loss, & volume of blood and blood products transfusions;Timepoint(s) of evaluation of this end point: 1. 4 minutes following TBS identification and through to final fascial closure 2. 10 minutes following TBS identification and through to final fascial closure 3. From TBS identification to final fascial closure 4. From TBS identification through 30 day follow up visit 5. From TBS identification through 30 day follow up visit 6. From TBS identification through 30 day follow up visit 7. From TBS identification through 30 day follow up visit 8. From baseline to discharge for laboratory results; from first incision to end of surgical procedure for blood loss; from first incision to the 30 day follow up visit for volume of blood and blood products transfusions | — |
Countries
United Kingdom, United States
Contacts
Public ContactClinical
Ethicon Inc.
Outcome results
None listed