Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery

NCT ID: NCT02891070

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-11
• Study Completion Date: 2018-08-22

Brief Summary

The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for use as an adjunct to sutured dural repair in cranial surgery.

Conditions

Cerebrospinal Fluid Leak

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

FS VH S/D 500 s-apr

FS VH S/D 500 s-apr (Tisseel), single use treatment, intraoperative

Group Type: EXPERIMENTAL

FS VH S/D 500 s-apr

Intervention Type: DRUG

DuraSeal Dural Sealant

DuraSeal Dural Sealant, single use treatment, intraoperative

Group Type: ACTIVE_COMPARATOR

DuraSeal Dural Sealant

Intervention Type: DEVICE

Interventions

FS VH S/D 500 s-apr

Intervention Type: DRUG

DuraSeal Dural Sealant

Intervention Type: DEVICE

Other Intervention Names

Tisseel

Eligibility Criteria

Inclusion Criteria

1. Patients undergoing craniotomy/craniectomy for pathological processes in the PF or ST region

2. Patients must be willing and able to participate in the study and provide written IC before any protocol specific assessment is performed

3. Patients must be willing to receive peri-operative antibiotic prophylaxis

4. Female patients of childbearing potential must present with a negative serum pregnancy test, and must agree to employ adequate birth control measures [restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products] for the duration of their participation in the study

5. Patients are willing and able to comply with the requirements of the protocol

Exclusion Criteria

1. Patients with a dural lesion from a recent surgery that still has the potential for CSF leakage

2. Patients who had undergone chemotherapy treatment, excluding hormonal therapy, within 3 weeks prior to the planned procedure, or with chemotherapy scheduled within 7 days following surgery

3. Patients with radiation therapy to the surgical site or standard fractionated radiation therapy scheduled within 7 days following surgery

4. Patients with a previous craniotomy/craniectomy within 6 months prior to the study surgery

5. Use of corticosteroids on a chronic basis (defined as daily use of corticosteroids for ≥8 weeks) for purposes other than decreasing the symptoms of systemic chemotherapy (unless if those steroids were discontinued 4 weeks prior to the planned surgery)

6. Patients with a known hypersensitivity to the components of the IP or control (human fibrinogen, synthetic aprotinin, human albumin, human FXIII, tri sodium citrate, histidine, niacinamide, polysorbate 80, human thrombin, polyethylene glycol [PEG], trilysine amine)

7. Patients with a known hypersensitivity to US Federal Drug & Cosmetic Blue #1 dye

8. Evidence of an infection indicated by any one of the following: clinical examination supporting the diagnosis of infection, fever (temperature >100.7°F or 38.2°C), positive urine culture, positive blood culture, positive chest X ray consistent with pulmonary infection, or infection along the planned surgical path. A white blood cell (WBC) count of <20000 cells/µL is permitted if the patient is being treated with steroids in the absence of all other infection parameters

9. Female patients of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period

10. Female patients who are nursing

11. Patients with exposure to another investigational drug or device clinical trial within 30 days prior to enrolment or anticipated in the 60-day Follow-up period

12. Patients with severely altered renal function as confirmed by local laboratory reference ranges for serum creatinine and/or hepatic function (alanine aminotransferase [ALT], aspartate aminotransferase >3 × upper limit of normal [ULN])

13. Patients who currently have or have had a compromised immune system (such as Acquired Immune Deficiency Syndrome [AIDS]) or autoimmune disease, or were on chronic immunosuppressant agents

14. Patients with uncontrolled diabetes as evidenced by the institution's standard of care (glycated haemoglobin [HbA1c] >7%, blood glucose, etc.)

15. Patients with traumatic injuries to the head

16. Patients with dural injury during craniotomy/craniectomy that cannot be eliminated by widening the craniotomy/craniectomy to recreate the native dural cuff

17. Patients requiring surgical approaches that would not allow sutured dural closure such as trans-sphenoidal or translabyrinthine/-petrosal/-mastoid. Superficial penetration of mastoid air cells is allowed

18. Patients with hydrocephalus, except occlusive hydrocephalus caused by PF pathology or incompletely open cerebrospinal fluid pathways, to be treated during surgical procedure

19. Existing CSF (ventricular, etc.) drains, Cushing/Dandy cannulation, or Burr holes which damage the dura

20. Patients with confined bony structures where nerves are present and neural compression may result due to swelling

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qing Li, MD, PhD

Role: STUDY_DIRECTOR

Baxter Healthcare

Locations

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Baystate Medical Center

Springfield, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Temple University School of Medicine

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Houston Methodist Neurological Institute

Houston, Texas, United States

University of Virginia School of Medicine

Charlottesville, Virginia, United States

University Hospital Brno

Brno, , Czechia

St. Anne's University Hospital Brno

Brno, , Czechia

University Hospital Hradec Kralove

Hradec Králové, , Czechia

University Hospital Ostrava

Ostrava, , Czechia

Hospital Na Homolce

Prague, , Czechia

University Hospital Motol

Praha 5 - Motol, , Czechia

University Hospital Leipzig

Leipzig, , Germany

Hospital Bogenhausen Municipal Hospital

Munich, , Germany

University Hospital Rostock

Rostock, , Germany

University Hospital Germans Trias I Pujol

Badalona, , Spain

Hospital Clinic I Provincial de Barcelona

Barcelona, , Spain

University Hospital Foundation Jimenez Diaz

Madrid, , Spain

University Hospital 12 de Octubre

Madrid, , Spain

University Hospital Son Espases

Palma de Mallorca, , Spain

University General Hospital of Valencia

Valencia, , Spain

Countries

United States; Czechia; Germany; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2015-005535-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3599-001

Identifier Type: -

Identifier Source: org_study_id