Clinical trial NCT03103282: Post-market Clinical Study to Confirm Safety and Performance of PuraStat® for the Management of Bleeding in Vascular Surgery.
Official title: A Multi-center, Single Arm Post-market Clinical Study to Confirm Safety and Performance of PuraStat® Absorbable Haemostatic Material for the Management of Bleeding In Vascular Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Anastomosis Surgery
Lead sponsor: 3-D Matrix Europe SAS
Sponsor class: INDUSTRY
First posted: 2017-04-06
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat®

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).

Eligibility criteria: 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

Primary outcomes:
measure: Total Time-To-Haemostasis
timeFrame: Intraoperatively
Secondary outcomes:
measure: Status Post Application(s)
timeFrame: Intraoperatively
measure: Blood Loss
timeFrame: Intraoperatively
measure: Total Drainage Volume
timeFrame: Post-operatively
measure: Transfusion of Blood Products
timeFrame: Intraoperatively
measure: Transfusion of Blood Products
timeFrame: Post-operatively
measure: Quantity of Blood Product(s) and or Substitute(s)
timeFrame: Intraoperatively
measure: Assessment of Product Use
timeFrame: Intraoperatively
measure: Length of Hospital Stay
timeFrame: Discharge
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George'S University Hospitals Nhs Foundation Trust
Study officials:
References: