The Paediatric EVICEL® Bleeding Study

• Research type

  Research Study

• Full title

  A Prospective, Randomised, Controlled Study Evaluating EVICEL® Fibrin Sealant as an Adjunct to Haemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) Surgery in Paediatric Patients

• IRAS ID

  148100

• Contact name

  Simon Kenny

• Contact email

  simon.kenny@alderhey.nhs.uk

• Sponsor organisation

  ETHICON

• Eudract number

  2013-003401-26

• Research summary

  This is a prospective, randomised, controlled study in paediatric patients evaluating the safety and effectiveness of EVICEL® compared with SURGICEL® for control of mild or moderate bleeding in soft tissue for which standard methods of achieving hemostasis are ineffective or impractical.

  Eligible subjects will be randomized in a 1:1 allocation ratio to either EVICEL® or SURGICEL® treatment. Subjects will be followed post-operatively through discharge and at 30 days (±14 days) post-surgery.

  Enrolment will be staggered by age. The first group enrolled will include subjects ≥9 years to <18 years of age and the subsequent group will include subjects from birth (including pre-term neonates born ≤ 37 weeks gestation) to <9 years of age. The randomly assigned treatment (EVICEL® or SURGICEL®) will be applied immediately at the actively bleeding TBS.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  14/NW/0176

• Date of REC Opinion

  16 May 2014

• REC opinion

  Further Information Favourable Opinion