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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  01/02/2008
 
Trade Name:  EVICEL
 
Generic or Proper Name (*):  Fibrin Sealant (Human)*
 
Indications Studied:  Adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical
 
Therapeutic Category:  Coagulant
 
Ages Studied:  2-16 years (retroperi-toneal and intra-abdominal surgery)
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Active Control
 
No Patients:  4
 
No Centers:  18
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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