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

A Prospective, Randomized, Controlled, Study Evaluating EVICEL® Fibrin Sealant as an Adjunct to Hemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) Surgery in Pediatric Patients - The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003401-26-GB

Enrollment

Registered

2013-12-06

Start date

2014-05-16

Completion date

Unknown

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) Surgery

Interventions

Trade Name: EVICEL® Product Name: EVICEL® Pharmaceutical Form: Solution for sealant INN or Proposed INN: HUMAN CLOTTABLE PROTEIN CAS Number: 9001-32-5 Other descriptive name: HUMAN CLOTTABLE PROTEIN C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pre-operative: 1. Paediatric subjects birth 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, 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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): • Haemostasis at 4, 7 and 10 minutes following randomization; • 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) • Incidence of adverse events (including thrombotic events and events associated with TBS rebleeding). • Proportion of subjects with no rebleeding; and • 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	—

Measure

Time frame

Secondary end point(s): • Haemostasis at 4, 7 and 10 minutes following randomization; • 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) • Incidence of adverse events (including thrombotic events and events associated with TBS rebleeding). • Proportion of subjects with no rebleeding; and • 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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Countries

Belgium, Canada, United Kingdom

Contacts

Public ContactClinical

Ethicon UK

ebarnett@its.jnj.com441506594675

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026