Trial Outcomes & Findings for Post-market Clinical Study to Confirm Safety and Performance of PuraStat® for the Management of Bleeding in Vascular Surgery. (NCT NCT03103282)

NCT ID: NCT03103282

Last Updated: 2020-12-10

Results Overview

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®.

• Recruitment status: COMPLETED
• Target enrollment: 65 participants
• Primary outcome timeframe: Intraoperatively
• Results posted on: 2020-12-10

Participant Flow

Participant milestones

Measure	PuraStat® Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat®
Overall Study STARTED	65
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	PuraStat® n=65 Participants Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat®
Age, Continuous	71.8 Years STANDARD_DEVIATION 8.9 • n=65 Participants
Sex: Female, Male Female	51 Participants n=65 Participants
Sex: Female, Male Male	14 Participants n=65 Participants
Region of Enrollment United Kingdom	53 participants n=65 Participants
Region of Enrollment Belgium	12 participants n=65 Participants

PRIMARY outcome

Timeframe: 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®.

Outcome measures

Measure	PuraStat® n=59 Participants Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat® in heparin or other antiplatelet treatments during the procedure.
Total Time-To-Haemostasis	83 Secondes Standard Deviation 105

SECONDARY outcome

Timeframe: Intraoperatively

Outcome measures

Measure	PuraStat® n=65 Participants Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat® in heparin or other antiplatelet treatments during the procedure.
Status Post Application(s) Complete Haemostasis	59 Participants
Status Post Application(s) Presence of bleeding	6 Participants

SECONDARY outcome

Timeframe: Intraoperatively

Outcome measures

Measure	PuraStat® n=64 Participants Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat® in heparin or other antiplatelet treatments during the procedure.
Blood Loss	127.0 mL Standard Deviation 111.4

SECONDARY outcome

Timeframe: Post-operatively

Outcome measures

Measure	PuraStat® n=52 Participants Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat® in heparin or other antiplatelet treatments during the procedure.
Total Drainage Volume	50.1 mL Standard Deviation 50.8

SECONDARY outcome

Timeframe: Intraoperatively

Outcome measures

Measure	PuraStat® n=65 Participants Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat® in heparin or other antiplatelet treatments during the procedure.
Transfusion of Blood Products NO	63 Participants
Transfusion of Blood Products YES	2 Participants

SECONDARY outcome

Timeframe: Post-operatively

Outcome measures

Measure	PuraStat® n=65 Participants Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat® in heparin or other antiplatelet treatments during the procedure.
Transfusion of Blood Products NO	65 Participants
Transfusion of Blood Products YES	0 Participants

SECONDARY outcome

Timeframe: Intraoperatively

Outcome measures

Measure	PuraStat® n=2 Participants Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat® in heparin or other antiplatelet treatments during the procedure.
Quantity of Blood Product(s) and or Substitute(s)	580.0 mL Standard Deviation 113.1

SECONDARY outcome

Timeframe: Intraoperatively

Outcome measures

Measure	PuraStat® n=65 Participants Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat® in heparin or other antiplatelet treatments during the procedure.
Assessment of Product Use Ease of preparation · Fair	0 Participants
Assessment of Product Use Ease of preparation · Excellent	49 Participants
Assessment of Product Use Ease of preparation · Good	16 Participants
Assessment of Product Use Ease of preparation · Poor	0 Participants
Assessment of Product Use Ease of application · Excellent	40 Participants
Assessment of Product Use Ease of application · Good	25 Participants
Assessment of Product Use Ease of application · Fair	0 Participants
Assessment of Product Use Ease of application · Poor	0 Participants

SECONDARY outcome

Timeframe: Discharge

Outcome measures

Measure	PuraStat® n=60 Participants Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat® in heparin or other antiplatelet treatments during the procedure.
Length of Hospital Stay	4.3 Days Standard Deviation 11.0

Adverse Events

PuraStat®

Serious events: 7 serious events

Other events: 20 other events

Deaths: 1 deaths

Serious adverse events

Measure	PuraStat® n=65 participants at risk Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat® in heparin or other antiplatelet treatments during the procedure.
Injury, poisoning and procedural complications Post procedural haematoma	1.5% 1/65 • At procedure, 1 day post-operative, 5-7 days post-operative, 1 month (± 15 days) post-operative
Nervous system disorders Stroke	4.6% 3/65 • At procedure, 1 day post-operative, 5-7 days post-operative, 1 month (± 15 days) post-operative
General disorders Death	1.5% 1/65 • At procedure, 1 day post-operative, 5-7 days post-operative, 1 month (± 15 days) post-operative
Infections and infestations Pneumonia	1.5% 1/65 • At procedure, 1 day post-operative, 5-7 days post-operative, 1 month (± 15 days) post-operative
Cardiac disorders Bradycardia	1.5% 1/65 • At procedure, 1 day post-operative, 5-7 days post-operative, 1 month (± 15 days) post-operative

Other adverse events

Measure	PuraStat® n=65 participants at risk Adult patients scheduled for elective carotid endarterectomy and who have been treated with PuraStat® in heparin or other antiplatelet treatments during the procedure.
Injury, poisoning and procedural complications Haemorrhage/Haematoma	3.1% 2/65 • At procedure, 1 day post-operative, 5-7 days post-operative, 1 month (± 15 days) post-operative
Injury, poisoning and procedural complications Other	27.7% 18/65 • At procedure, 1 day post-operative, 5-7 days post-operative, 1 month (± 15 days) post-operative

Additional Information

Florian REBECA

3-D Matrix Europe SAS

Phone: +33617587769

Email: frebeca@puramatrix.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60