Controlling Mild to Moderate Bleeding During Surgery Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 35 |
| Est. completion date | June 30, 2025 |
| Est. primary completion date | June 1, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 28 Days to 17 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Birmingham Chrildren's Hospital | Birmingham | |
| United Kingdom | Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne | |
| United Kingdom | Southampton University Hospital | Southampton | |
| United States | The Johns Hopkins Hospital | Baltimore | Maryland |
| United States | University of Alabama Hospital | Birmingham | Alabama |
| United States | Nemours Children's Specialty Care | Jacksonville | Florida |
| United States | University of Kentucky | Lexington | Kentucky |
| United States | icahn School of Medicine at Mt Sinai | New York | New York |
| United States | Univesity of Utah | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Ethicon, Inc. |
United States, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Absolute time to hemostasis | The absolute time to hemostasis, defined as the absolute time elapsed from TBS identification to the last moment in time at which detectable bleeding at the TBS is observed. | Intraoperative from TBS identification to the last moment in time at which no detectable bleeding at the TBS is observed | |
| Secondary | Hemostatic success at 4 minutes | Proportion of subjects achieving hemostatic success at 4 minutes following Target Bleeding Site (TBS) identification and no bleeding requiring treatment at the TBS any time prior to final fascial closure. | Intraoperative, 4 minutes after TBS identification | |
| Secondary | Hemostatic success at 10 minutes | Proportion of subjects achieving hemostatic success at 10 minutes following TBS identification and no bleeding requiring treatment at the TBS any time prior to final fascial closure. | Intraoperative, 10 minutes after TBS identification | |
| Secondary | No re-bleeding at the TBS | Proportion of subjects with no re-bleeding at the TBS. | Intraoperative, from TBS identification to final fascial closure | |
| Secondary | Incidence of adverse events that are potentially related to bleeding at the TBS | Incidence of adverse events that are potentially related to bleeding at the TBS. | Intraoperative to 30 (+/- 14) days | |
| Secondary | Incidence of adverse events that are potentially related to thrombotic events | Incidence of adverse events that are potentially related to thrombotic events. | Intraoperative to 30 (+/- 14) days | |
| Secondary | Incidence of re-treatment at the TBS | Intraoperative, from TBS identification to final fascial closure | ||
| Secondary | Incidence of Adverse Events | Intraoperative to 30 (+/- 14) days | ||
| Secondary | Number of Participants with Abnormalities in Clinical Laboratory Tests | Number of participants with abnormalities in clinical laboratory tests (hemoglobin, hematocrit, and platelets) will be reported. | Intraoperative to 30 days | |
| Secondary | Number of Participants with Estimated Intraoperative Blood Loss | Number of participants with estimated intraoperative blood loss will be reported. | Intraoperative to 30 days | |
| Secondary | Number of Participants with Blood products Transfused | Number of participants with blood products transfused will be reported. | Intraoperative to 30 days |