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

Completed

• Conditions: Vascular Anastomosis Surgery

• Registration Number: NCT03103282
• Lead Sponsor: 3-D Matrix Europe SAS

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-06
• Study Start: 2017-06-14
• Primary Completion: 2019-07-05
• Study Completion: 2019-08-30
• Status Verified: 2020-11
• Results First Submitted: 2020-11-13
• Results First Submitted QC: 2020-11-13
• Last Update Submitted: 2020-11-13
• Results First Posted: 2020-12-10
• Last Update Posted: 2020-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

St George'S University Hospitals Nhs Foundation Trust; 🇬🇧 London, United Kingdom