NCT02034799

Phase IV Bioseal Study in Brain Tumor Surgery

Completed Phase 4 Results posted Last updated 26 February 2018

What this trial tests

Phase 4 trial testing Bioseal Fibrin Sealant in Hemostasis in 256 participants. Completed in 1 September 2014.

Timeline

1 November 2013

Primary endpoint
1 August 2014

1 September 2014

Quick facts

Lead sponsor	Ethicon, Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	256
Start date	1 November 2013
Primary completion	1 August 2014
Estimated completion	1 September 2014
Sites	7 locations across China

Drugs / interventions tested

• Bioseal Fibrin Sealant — full drug profile →
• Standard of Care (SoC) — full drug profile →

Conditions studied

• Hemostasis — all drugs for Hemostasis →
• Meningioma Surgery — all drugs for Meningioma Surgery →

Sponsor

Ethicon, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Hemostasis or Meningioma Surgery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Standard of Care (SoC)	99.2	95.8 – 100
Bioseal Fibrin Sealant	100	97.1 – 100

Hemostasis at the TBS at 3 Minutes Following Treatment Application Secondary · 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.

Group	Value	95% CI
Standard of Care (SoC)	89.9	83.4 – 94.5
Bioseal Fibrin Sealant	94.5	89.0 – 97.8

Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications. Secondary · Through 30-day follow-up

Neurosurgical Complication

Group	Value	95% CI
Standard of Care (SoC)	14
Bioseal Fibrin Sealant	14

Unplanned Intervention

Group	Value	95% CI
Standard of Care (SoC)	5
Bioseal Fibrin Sealant	3

Central Nervous System

Group	Value	95% CI
Standard of Care (SoC)	6
Bioseal Fibrin Sealant	8

Surgical Wound Complication

Group	Value	95% CI
Standard of Care (SoC)	5
Bioseal Fibrin Sealant	3

Incidence of Potential Bleeding-related Adverse Events Secondary · Through 30-day follow-up

Group	Value	95% CI
Standard of Care (SoC)	18
Bioseal Fibrin Sealant	18

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were assessed and recorded from the time of treatment application until completion of the 30 (± 7) days follow up period.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard of Care (SoC)

Serious: 10/129 (8%)

Deaths: —

Bioseal Fibrin Sealant

Serious: 5/127 (4%)

Deaths: —

Serious adverse events (13 terms)

Reaction	System	Standard of Care (SoC)	Bioseal Fibrin Sealant
Extradural Haematoma	Injury, poisoning and procedural complications	—	—
Pneumonia	Infections and infestations	—	—
Postoperative Wound Infection	Infections and infestations	—	—
Brain Herniation	Injury, poisoning and procedural complications	—	—
Head Injury	Injury, poisoning and procedural complications	—	—
Subdural Haemorrhage	Injury, poisoning and procedural complications	—	—
Fibrinolysis	Investigations	—	—
Glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Malignant Neoplasm Progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Brain Oedema	Nervous system disorders	—	—
Cerebral Ischaemia	Nervous system disorders	—	—
VIIth Nerve Paralysis	Nervous system disorders	—	—
Deep Vein Thrombosis	Vascular disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Standard of Care (SoC)	Bioseal Fibrin Sealant
Anemia	Blood and lymphatic system disorders	—	—
Brain Oedema	Nervous system disorders	—	—
Pyrexia	General disorders	—	—
Lung Infection	Infections and infestations	—	—

Most-reported serious reactions: Extradural Haematoma, Pneumonia, Postoperative Wound Infection, Brain Herniation, Head Injury, Subdural Haemorrhage, Fibrinolysis, Glioma.

Data from ClinicalTrials.gov NCT02034799 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A multicenter, prospective, randomized clinical study to evaluate the efficacy and safety of fibrin sealant as an adjunct to sutured dural repair.
   Yu R, Zhu W, Kocharian R, Ilie B, et al · · 2022 · cited 3× · PMID 36583870 · DOI 10.1097/cm9.0000000000002413