The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study

Phase 3 Completed 40 enrolled Ethicon, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.

Timeline

Start: 2014-08-01
Primary completion: 2019-04-17
Completion: 2019-05-17

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fibrinogen Concentrate Human	Protein / enzyme biologic	—	—

The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study

Summary

Timeline

Drugs

Indications