Trial Outcomes & Findings for The Bioseal Vascular Study (NCT NCT02094885)

NCT ID: NCT02094885

Last Updated: 2018-03-08

Results Overview

Percentage of participants with Hemostasis at the TBS at 10 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

252 participants

Primary outcome timeframe

Intra-operative, 10 minutes following randomization

Results posted on

2018-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	Bioseal Fibrin Sealant A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.	Manual Compression Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
Overall Study STARTED	125	127
Overall Study COMPLETED	123	122
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Bioseal Fibrin Sealant A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.	Manual Compression Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
Overall Study Death	1	5
Overall Study Withdrawn due to age	1	0

Baseline Characteristics

The Bioseal Vascular Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bioseal Fibrin Sealant n=125 Participants A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.	Manual Compression n=127 Participants Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.	Total n=252 Participants Total of all reporting groups
Age, Continuous	57.1 years STANDARD_DEVIATION 13.0 • n=5 Participants	56.8 years STANDARD_DEVIATION 12.2 • n=7 Participants	56.9 years STANDARD_DEVIATION 12.6 • n=5 Participants
Age, Customized <=60 years	63 Participants n=5 Participants	64 Participants n=7 Participants	127 Participants n=5 Participants
Age, Customized >60,<=75 years	60 Participants n=5 Participants	63 Participants n=7 Participants	123 Participants n=5 Participants
Age, Customized >75	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	33 Participants n=7 Participants	68 Participants n=5 Participants
Sex: Female, Male Male	90 Participants n=5 Participants	94 Participants n=7 Participants	184 Participants n=5 Participants
BMI	23.9 kg/m^2 STANDARD_DEVIATION 3.4 • n=5 Participants	23.8 kg/m^2 STANDARD_DEVIATION 3.2 • n=7 Participants	23.9 kg/m^2 STANDARD_DEVIATION 3.3 • n=5 Participants
BMI Group Underweight	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
BMI Group Normal	75 participants n=5 Participants	79 participants n=7 Participants	154 participants n=5 Participants
BMI Group Overweight	41 participants n=5 Participants	39 participants n=7 Participants	80 participants n=5 Participants
BMI Group Obese	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Height	168.0 cm n=5 Participants	167.0 cm n=7 Participants	168.0 cm n=5 Participants
Weight	67.0 kg n=5 Participants	66.0 kg n=7 Participants	66.0 kg n=5 Participants
Smoking Status Current Smoker	39 participants n=5 Participants	31 participants n=7 Participants	70 participants n=5 Participants
Smoking Status Former Smoker	15 participants n=5 Participants	17 participants n=7 Participants	32 participants n=5 Participants
Smoking Status Never Smoked	71 participants n=5 Participants	79 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: Intra-operative, 10 minutes following randomization

Percentage of participants with Hemostasis at the TBS at 10 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.

Outcome measures

Outcome measures
Measure	Bioseal Fibrin Sealant n=125 Participants A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.	Manual Compression n=127 Participants Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.	96 percentage of patients Interval 90.9 to 98.7	88.2 percentage of patients Interval 81.3 to 93.2

SECONDARY outcome

Timeframe: Intra-operative, 3 and 6 minutes following randomization

Percentage of participants with Hemostasis at the TBS at 3 and 6 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.

Outcome measures

Outcome measures
Measure	Bioseal Fibrin Sealant n=125 Participants A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.	Manual Compression n=127 Participants Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application Hemostasis at 3 Minutes	84 percentage of participants Interval 76.4 to 89.9	43.3 percentage of participants Interval 34.5 to 52.4
Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application Hemostasis at 6 Minutes	96.0 percentage of participants Interval 90.9 to 98.7	74.0 percentage of participants Interval 65.5 to 81.4

SECONDARY outcome

Timeframe: Intra-operative, 10 minutes following randomization

Alternative treatments include the use of additional hemostatic methods, including collagen, manual compression, oxidized regenerated cellulose and suture. Manual compression (MC) may be applied after the initial 10 minute observation period as an alternative treatment due to treatment failure in either group. For participants with a treatment failure in MC group, the addition treatment of MC is applied after the initial 10 minute observation period.

Outcome measures

Outcome measures
Measure	Bioseal Fibrin Sealant n=125 Participants A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.	Manual Compression n=127 Participants Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
Number of Participants Requiring Alternative Treatment Due to Treatment Failure* Total number requiring alternative treatment	5 participants	15 participants
Number of Participants Requiring Alternative Treatment Due to Treatment Failure* Treated with Collagen	0 participants	2 participants
Number of Participants Requiring Alternative Treatment Due to Treatment Failure* Treated with Manual Compression After 10 Minutes*	1 participants	1 participants
Number of Participants Requiring Alternative Treatment Due to Treatment Failure* Treated with Oxidized Regenerated Cellulose	2 participants	8 participants
Number of Participants Requiring Alternative Treatment Due to Treatment Failure* Treated with Suture	2 participants	4 participants

SECONDARY outcome

Timeframe: 30-days follow-up

Percentage of participants with potential bleeding-related adverse events by study group

Outcome measures

Outcome measures
Measure	Bioseal Fibrin Sealant n=125 Participants A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.	Manual Compression n=127 Participants Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
Percentage of Participants With Potential Bleeding-related Adverse Events	2.4 percentage of participants Interval 0.5 to 6.9	2.4 percentage of participants Interval 0.5 to 6.7

Adverse Events

Bioseal Fibrin Sealant

Serious events: 13 serious events

Other events: 15 other events

Deaths: 0 deaths

Manual Compression

Serious events: 11 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Bioseal Fibrin Sealant n=125 participants at risk A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.	Manual Compression n=127 participants at risk Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
Cardiac disorders Arrhythmia	2.4% 3/125 • Number of events 3 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.	0.00% 0/127 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.
Cardiac disorders Atrial Fibrillation	0.80% 1/125 • Number of events 1 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.	2.4% 3/127 • Number of events 3 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.
Cardiac disorders Myocardial Infarction	1.6% 2/125 • Number of events 2 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.	0.79% 1/127 • Number of events 1 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.
Cardiac disorders Ventricular Tachycardia	1.6% 2/125 • Number of events 2 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.	0.79% 1/127 • Number of events 1 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.
Hepatobiliary disorders Hepatic Failure	0.00% 0/125 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.	1.6% 2/127 • Number of events 2 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.
Infections and infestations Lung Infection	1.6% 2/125 • Number of events 2 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.	0.79% 1/127 • Number of events 1 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.
Infections and infestations Pneumonia	1.6% 2/125 • Number of events 2 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.	0.79% 1/127 • Number of events 1 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.
Investigations Platelet Count Decreased	0.00% 0/125 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.	1.6% 2/127 • Number of events 2 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.4% 3/125 • Number of events 3 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.	1.6% 2/127 • Number of events 2 • AEs were collected from the start of randomization during the procedure until completion of the 30 day follow-up visit.

Additional Information

Jonathan Batiller, Senior Clinical Director

Ethicon, Inc

Phone: +1 908 218-2492

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60