Human medicines European public assessment report (EPAR): VeraSeal, human fibrinogen,human thrombin, Date of authorisation: 10/11/2017, Revision: 8, Status: Authorised
Three main studies in 614 patients, mainly adults, found that VeraSeal is effective at stopping bleeding within 4 minutes of applying it during surgery.
In one study of blood vessel surgery, VeraSeal worked better than manual compression, with 76% of patients having no bleeding 4 minutes after treatment with VeraSeal (83 out of 109), compared with 23% after manual compression (13 out of 57).
In a second study of organ surgery, VeraSeal was as effective as another product Surgicel: 93% of the patients had no bleeding 4 minutes after treatment with VeraSeal (103 out of 111), while 81% of the patients had no bleeding with Surgicel (91 out of 113).
In a third study of soft tissue surgery, VeraSeal was as effective as Surgicel: 83% of the patients had no bleeding 4 minutes after treatment with VeraSeal (96 out of 116), compared with 78% of the patients after treatment with Surgicel (84 out of 108).
A fourth study was carried out in 178 children and adolescents who received either VeraSeal or another medicine containing fibrinogen and thrombin (Evicel) to stop bleeding during surgery. In this study, 97% (88 out of 91) of patients given VeraSeal had no bleeding 4 minutes after treatment and no new bleeding requiring treatment until the end of the surgery, compared with 95% (83 out of 87) of patients given Evicel.
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