Title

Phase IV Bioseal Study in Brain Tumor Surgery
A Prospective, Randomized, Controlled Phase IV Study to Compare Bioseal Versus Standard of Care as an Adjunct to Hemostasis in Elective Brain Tumor Surgery
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Intervention/Treatment

    human fibrin ...
  • Study Participants

    256
The objective of this study is to observe the clinical utility and performance of Bioseal when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma surgery.
Study Started
Nov 01
2013
Primary Completion
Aug 01
2014
Study Completion
Sep 01
2014
Results Posted
Feb 26
2018
Last Update
Feb 26
2018

Biological Bioseal Fibrin Sealant

Other Standard of Care (SoC)

Standard of Care (SoC) Other

Standard of Care (SoC) 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.

Bioseal Fibrin Sealant Experimental

A porcine-derived fibrin sealant consisting of thrombin and fibrinogen

Criteria

Inclusion Criteria:

Subjects between 18 and 75 years of age
Undergoing elective meningioma surgery and having a tumor cavity
Presence of an appropriate Target Bleeding Site (TBS) as identified intra-operatively by the surgeon requiring an adjunct to achieve hemostasis
Able and willing to comply with procedures required by protocol
Signed and dated written informed consent prior to any study related procedures.

Exclusion Criteria:

Subjects undergoing emergency surgery
Subjects with any intra-operative findings that may preclude conducting of the study procedures
Intended use of Fibrin Sealants (including autologous Fibrin Sealants) other than Bioseal on the Target Bleeding Site (TBS)
Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products
Subjects who have a history of traumatic head injury
Female subjects who are known breastfeeding or pregnant or intend to become pregnant during the clinical study period
The subject, in the opinion of the investigator, would not be suitable for participation in the study
Subjects who participated in another trial within 30 days prior to the planned start of treatment.

Summary

Standard of Care (SoC)

Bioseal Fibrin Sealant

All Events

Event Type Organ System Event Term Standard of Care (SoC) Bioseal Fibrin Sealant

Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS.

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.

Standard of Care (SoC)

99.2
% of participants
95% Confidence Interval: 95.8 to 100.0

Bioseal Fibrin Sealant

100.0
% of participants
95% Confidence Interval: 97.1 to 100.0

Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.

Standard of Care (SoC)

Central Nervous System

6.0
participants

Neurosurgical Complication

14.0
participants

Surgical Wound Complication

5.0
participants

Unplanned Intervention

5.0
participants

Bioseal Fibrin Sealant

Central Nervous System

8.0
participants

Neurosurgical Complication

14.0
participants

Surgical Wound Complication

3.0
participants

Unplanned Intervention

3.0
participants

Incidence of Potential Bleeding-related Adverse Events

Standard of Care (SoC)

18.0
participants

Bioseal Fibrin Sealant

18.0
participants

Hemostasis at the TBS at 3 Minutes Following Treatment Application

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.

Standard of Care (SoC)

89.9
% of participants
95% Confidence Interval: 83.4 to 94.5

Bioseal Fibrin Sealant

94.5
% of participants
95% Confidence Interval: 89.0 to 97.8

Total

256
Participants

Age, Continuous

49.8
years (Mean)
Standard Deviation: 11.5

BMI

23.2
(kg/m^2) (Mean)
Standard Deviation: 3.1

BMI

22.8
(kg/m^2) (Median)
Full Range: 17.0 to 34.7

Height

164.1
cm (Mean)
Standard Deviation: 7.3

Height

162
cm (Median)
Full Range: 141.0 to 180.0

Weight

61
kg (Median)
Full Range: 40.0 to 98.0

Weight

62.6
kg (Mean)
Standard Deviation: 9.6

Age, Categorical

BMI Group

Sex: Female, Male

Smoking Status

Overall Study

Standard of Care (SoC)

Bioseal Fibrin Sealant

Drop/Withdrawal Reasons

Standard of Care (SoC)

Bioseal Fibrin Sealant