Post-market Clinical Study to Confirm Safety and Performance of PuraStat® for the Management of Bleeding in Vascular Surgery.

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).

• PuraStat® (Device): Synthetic haemostatic material

Primary outcomes

• Total Time-To-Haemostasis [Intraoperatively]: 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®.

Secondary outcomes

• Status Post Application(s) [Intraoperatively]
• Blood Loss [Intraoperatively]
• Total Drainage Volume [Post-operatively]
• Transfusion of Blood Products [Intraoperatively]
• Transfusion of Blood Products [Post-operatively]
• Quantity of Blood Product(s) and or Substitute(s) [Intraoperatively]
• Assessment of Product Use [Intraoperatively]
• Length of Hospital Stay [Discharge]

Sex: All, ages: 18 Years to any

Main Inclusion criteria:

1. Male or female patient ≥18 years old
2. Subject undergoing elective carotid endarterectomy
3. Subject who is able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained
4. Subject, who, in the opinion of the Clinical Investigator, is able to understand this clinical study, cooperate with the study procedures and is willing to return for the required post-treatment follow-up
5. Intra-operative inclusion criteria: Subject requiring the use of PuraStat® for haemostasis during elective carotid endarterectomy either by direct closure (without the use of patch), or by patch reconstruction or eversion technique when haemostasis by ligation or standard means is insufficient or impractical.

Main exclusion criteria:

1. Presence or sequelae of coagulation disorder
2. Known allergy or hypersensitivity to any component of PuraStat®
3. Concurrent participation in another clinical trial with a medical device or a medicinal product
4. Pregnant or interested in becoming pregnant during the duration of the study, or breast feeding

   Intra-operative exclusion criteria:
5. Spurting and/or gushing haemorrhage site(s)
6. Contaminated or potentially contaminated surgical area
7. Fibrin glue and/or topical haemostatic agent used before or concomitantly to the use of PuraStat®
8. Persistent major bleeding after conventional haemostasis

Participant flow

Outcome results

• Total Time-To-Haemostasis (Primary), Mean, Secondes: PuraStat® 83 +/- 105
• Status Post Application(s) (Secondary), Count of participants, Participants: PuraStat® 59
• Blood Loss (Secondary), Mean, mL: PuraStat® 127.0 +/- 111.4
• Total Drainage Volume (Secondary), Mean, mL: PuraStat® 50.1 +/- 50.8
• Transfusion of Blood Products (Secondary), Count of participants, Participants: PuraStat® 63
• Transfusion of Blood Products (Secondary), Count of participants, Participants: PuraStat® 65
• Quantity of Blood Product(s) and or Substitute(s) (Secondary), Mean, mL: PuraStat® 580.0 +/- 113.1
• Assessment of Product Use (Secondary), Count of participants, Participants: PuraStat® 49
• Length of Hospital Stay (Secondary), Mean, Days: PuraStat® 4.3 +/- 11.0

Adverse events

Time frame: At procedure, 1 day post-operative, 5-7 days post-operative, 1 month (± 15 days) post-operative

Serious adverse events by term

Other adverse events by term

• Statistical Analysis Plan (PDF, 2019-12-02)
• Study Protocol (PDF, 2019-03-19)