The objective of this post-market clinical follow-up study is to collect medical information on patients implanted with PuraStat®, according to each participating institution's procedures and standards of care.
This multicentre, single arm post-market clinical study aims to collect medical information on patients implanted with PuraStat®, Absorbable Haemostatic Material, according to each participating institution's procedures and standards of care for confirming the safety and the performance of PuraStat®, for the management of bleeding in vascular surgery (Carotid Endarterectomy either by direct closure (without the use of patch), or by patch reconstruction or eversion technique).
Study Type
OBSERVATIONAL
Enrollment
65
Synthetic haemostatic material
St George'S University Hospitals Nhs Foundation Trust
London, United Kingdom
Total Time-To-Haemostasis
Total Time-To-Haemostasis (TTH) will be intraoperatively measured (secondes) from the first application of PuraStat® to a bleeding site after clamp release, until all bleeding at that site has ceased. In case of rebleeding of the treated sites and additional application of PuraStat®, the TTH will be calculated by the addition of TTH1+ TTH(n+1), where TTH1+ TTH(n+1) are the time to haemostasis after each application of PuraStat®.
Time frame: Intraoperatively
Status Post Application(s)
Time frame: Intraoperatively
Blood Loss
Time frame: Intraoperatively
Total Drainage Volume
Time frame: Post-operatively
Transfusion of Blood Products
Time frame: Intraoperatively
Transfusion of Blood Products
Time frame: Post-operatively
Quantity of Blood Product(s) and or Substitute(s)
Time frame: Intraoperatively
Assessment of Product Use
Time frame: Intraoperatively
Length of Hospital Stay
Time frame: Discharge
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