Trial Outcomes & Findings for Phase IV Bioseal Study in Brain Tumor Surgery (NCT NCT02034799)

NCT ID: NCT02034799

Last Updated: 2018-02-26

Results Overview

The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 6 minutes following start of treatment application. Hemostasis is defined as no detectable bleeding at the TBS.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

256 participants

Primary outcome timeframe

Intra-operative, 6 minutes following randomization

Results posted on

2018-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	Standard of Care (SoC) SoC include Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).	Bioseal Fibrin Sealant A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
Overall Study STARTED	129	127
Overall Study COMPLETED	127	123
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard of Care (SoC) SoC include Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).	Bioseal Fibrin Sealant A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
Overall Study Withdrawal by Subject	0	2
Overall Study Lost to Follow-up	0	1
Overall Study Death	2	1

Baseline Characteristics

Phase IV Bioseal Study in Brain Tumor Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care (SoC) n=129 Participants Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH). Standard of Care (SoC)	Bioseal Fibrin Sealant n=127 Participants A porcine-derived fibrin sealant consisting of thrombin and fibrinogen Bioseal Fibrin Sealant	Total n=256 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	1 Participants n=41 Participants	1 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	106 Participants n=39 Participants	98 Participants n=41 Participants	204 Participants n=35 Participants
Age, Categorical >=65 years	23 Participants n=39 Participants	28 Participants n=41 Participants	51 Participants n=35 Participants
Age, Continuous	48.9 years STANDARD_DEVIATION 11.3 • n=39 Participants	50.7 years STANDARD_DEVIATION 11.7 • n=41 Participants	49.8 years STANDARD_DEVIATION 11.5 • n=35 Participants
Sex: Female, Male Female	69 Participants n=39 Participants	80 Participants n=41 Participants	149 Participants n=35 Participants
Sex: Female, Male Male	60 Participants n=39 Participants	47 Participants n=41 Participants	107 Participants n=35 Participants
Height	163 cm n=39 Participants	161 cm n=41 Participants	162 cm n=35 Participants
Weight	62 kg n=39 Participants	60 kg n=41 Participants	61 kg n=35 Participants
BMI	22.5 (kg/m^2) n=39 Participants	23.1 (kg/m^2) n=41 Participants	22.8 (kg/m^2) n=35 Participants
BMI Group Underweight	3 participants n=39 Participants	2 participants n=41 Participants	5 participants n=35 Participants
BMI Group Normal	96 participants n=39 Participants	95 participants n=41 Participants	191 participants n=35 Participants
BMI Group Overweight	22 participants n=39 Participants	27 participants n=41 Participants	49 participants n=35 Participants
BMI Group Obese	8 participants n=39 Participants	3 participants n=41 Participants	11 participants n=35 Participants
Smoking Status Current Smoker	18 participants n=39 Participants	12 participants n=41 Participants	30 participants n=35 Participants
Smoking Status Former Smoker	4 participants n=39 Participants	3 participants n=41 Participants	7 participants n=35 Participants
Smoking Status Never Smoked	107 participants n=39 Participants	112 participants n=41 Participants	219 participants n=35 Participants

PRIMARY outcome

Timeframe: Intra-operative, 6 minutes following randomization

The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 6 minutes following start of treatment application. Hemostasis is defined as no detectable bleeding at the TBS.

Outcome measures

Outcome measures
Measure	Standard of Care (SoC) n=129 Participants Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).	Bioseal Fibrin Sealant n=127 Participants A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS.	99.2 % of participants Interval 95.8 to 100.0	100 % of participants Interval 97.1 to 100.0

SECONDARY outcome

Timeframe: Intra-operative, 3 minutes following randomization

The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 3 minutes following start of treatment application. Hemostasis was defined as no detectable bleeding at the TBS.

Outcome measures

Outcome measures
Measure	Standard of Care (SoC) n=129 Participants Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).	Bioseal Fibrin Sealant n=127 Participants A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
Hemostasis at the TBS at 3 Minutes Following Treatment Application	89.9 % of participants Interval 83.4 to 94.5	94.5 % of participants Interval 89.0 to 97.8

SECONDARY outcome

Timeframe: Through 30-day follow-up

Outcome measures

Outcome measures
Measure	Standard of Care (SoC) n=129 Participants Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).	Bioseal Fibrin Sealant n=127 Participants A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications. Neurosurgical Complication	14 participants	14 participants
Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications. Unplanned Intervention	5 participants	3 participants
Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications. Central Nervous System	6 participants	8 participants
Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications. Surgical Wound Complication	5 participants	3 participants

SECONDARY outcome

Timeframe: Through 30-day follow-up

Outcome measures

Outcome measures
Measure	Standard of Care (SoC) n=129 Participants Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).	Bioseal Fibrin Sealant n=127 Participants A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
Incidence of Potential Bleeding-related Adverse Events	18 participants	18 participants

Adverse Events

Standard of Care (SoC)

Serious events: 10 serious events

Other events: 22 other events

Deaths: 0 deaths

Bioseal Fibrin Sealant

Serious events: 5 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard of Care (SoC) n=129 participants at risk Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).	Bioseal Fibrin Sealant n=127 participants at risk A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
Infections and infestations Pneumonia	0.00% 0/129 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	0.79% 1/127 • Number of events 1 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.
Infections and infestations Postoperative Wound Infection	0.78% 1/129 • Number of events 1 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	0.79% 1/127 • Number of events 1 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.
Injury, poisoning and procedural complications Brain Herniation	0.78% 1/129 • Number of events 1 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	0.00% 0/127 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.
Injury, poisoning and procedural complications Extradural Haematoma	1.6% 2/129 • Number of events 2 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	0.00% 0/127 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.
Injury, poisoning and procedural complications Head Injury	0.78% 1/129 • Number of events 1 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	0.00% 0/127 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.
Injury, poisoning and procedural complications Subdural Haemorrhage	0.78% 1/129 • Number of events 1 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	0.00% 0/127 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.
Investigations Fibrinolysis	0.78% 1/129 • Number of events 1 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	0.00% 0/127 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	0.00% 0/129 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	0.79% 1/127 • Number of events 1 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Progression	0.78% 1/129 • Number of events 1 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	0.00% 0/127 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.
Nervous system disorders Brain Oedema	0.78% 1/129 • Number of events 1 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	0.00% 0/127 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.
Nervous system disorders Cerebral Ischaemia	0.78% 1/129 • Number of events 1 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	0.79% 1/127 • Number of events 1 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.
Nervous system disorders VIIth Nerve Paralysis	0.78% 1/129 • Number of events 1 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	0.00% 0/127 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.
Vascular disorders Deep Vein Thrombosis	0.00% 0/129 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	0.79% 1/127 • Number of events 1 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.

Other adverse events

Other adverse events
Measure	Standard of Care (SoC) n=129 participants at risk Standard of Care (SoC) included manual compression, cautery, manual compression and cautery with a non-fibrin sealant topical absorbable hemostat (TAH).	Bioseal Fibrin Sealant n=127 participants at risk A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
Blood and lymphatic system disorders Anemia	6.2% 8/129 • Number of events 8 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	8.7% 11/127 • Number of events 11 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.
General disorders Pyrexia	3.1% 4/129 • Number of events 4 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	5.5% 7/127 • Number of events 7 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.
Infections and infestations Lung Infection	5.4% 7/129 • Number of events 7 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	1.6% 2/127 • Number of events 2 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.
Nervous system disorders Brain Oedema	6.2% 8/129 • Number of events 8 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.	4.7% 6/127 • Number of events 6 • Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.

Additional Information

Senior Director of Ethicon Clinical R&D

Ethicon, Inc

Phone: (908) 218-2492

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60