A study of the safety and effectiveness of EVICEL® as a treatment in addition to standard techniques of stopping bleeding during abdominal surgery in childre

Phase 1

Conditions: Abdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) Surgery
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2013-003401-26-GB

Lead Sponsor: Ethicon Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Pre-operative:
1. Paediatric subjects birth to < 18 years of age, requiring non-emergent laparoscopic or open abdominal, retroperitoneal, pelvic, or thoracic (non-cardiac) surgical procedures;
2. The subject’s and/or subject’s parent or legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. If possible, assent must be obtained from paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the paediatric 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.

Intra-operative:
3. Presence of an appropriate mild or moderate bleeding soft tissue or parenchymal organ Target Bleeding Site identified intra-operatively by the surgeon;
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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, who are of childbearing age (i.e. adolescent), who are pregnant or nursing;
3. Subject is currently participating or, during the study is planned to participate in any other investigational device or drug trial 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. Anastomotic bleeding sites will not be considered for randomization

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve hemostasis during surgery in pediatric patients.;Secondary Objective: Not applicable;Primary end point(s): Absolute time to haemostasis; defined as absolute time when there is no detectable bleeding at the Target Bleeding Site (TBS).;Timepoint(s) of evaluation of this end point: starting from randomization and until hemostasis is achieved

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Haemostasis at 4, 7 and 10 minutes following randomization;<br>• Incidence of treatment failure (defined as haemostasis not achieved within 10 minutes or bleeding at the TBS during the ten-minute observational period that requires further haemostatic measures other than re-application of the assigned haemostatic adjunct)<br>• Incidence of adverse events (including thrombotic events and events associated with TBS rebleeding).<br>• Proportion of subjects with no rebleeding; and<br>• Haemoglobin, Haematocrit, Platelets, Volume of blood loss, Volume of blood and blood products transfusions;Timepoint(s) of evaluation of this end point: Subjects will be followed post-operatively for secondary end-points through hospital discharge and at 30 days (±14 days) post-surgery

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