A study of the superior effect of EVARREST™ Fibrin Sealant Patch as compared to Standard Treatment in controlling bleeding during liver surgery

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2013-002535-24-GB
• Date of registration: 13/08/2013
• Prospective Registration: Yes
• Primary sponsor: Ethicon Inc., a Johnson & Johnson Co.
• Public title: A study of the superior effect of EVARREST™ Fibrin Sealant Patch as compared to Standard Treatment in controlling bleeding during liver surgery
• Scientific title: A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST™ Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery
• Date of first enrolment: 20/09/2013
• Target sample size: 90
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002535-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Standard of Care Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, New Zealand, United Kingdom, United States

Contacts

• Name: Clinical Development
• Affiliation: Johnson & Johnson Medical Ltd.

• Name: Clinical Development
• Affiliation: Johnson & Johnson Medical Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
1.Subjects > 18 years of age, requiring elective or urgent, open hepatic surgery.
2. Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as identified intra-operatively by the surgeon;
3. Subjects must be willing to participate in the study, and provide written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion criteria:
1.Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
2.TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST™ to blood flow and pressure during healing and absorption of the product;
3. TBS with major arterial bleeding requiring suture or mechanical ligation;
4. Subjects admitted for trauma surgery;
5. Subject is a transplant patient for fulminant hepatic failure
6. Subject with TBS within an actively infected field;
7. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
8. Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
9. Subjects who are known, current alcohol and / or drug abusers;
10. Subjects who have participated in another medical device or investigational drug trial within 30 days of surgery;
11. Female subjects who are pregnant or nursing.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Subjects undergoing elective, open, hepatic surgery during which a resection plane is created and wherein an appropriate Target Bleeding Site is identified

Intervention(s)

Trade Name: EVARREST Fibrin Sealant Patch
Product Name: EVARREST Fibrin Sealant Patch
Pharmaceutical Form: Impregnated pad
INN or Proposed INN: HUMAN FCLOTTABLE PROTEIN
CAS Number: CAS9001-32-5
Other descriptive name: HUMAN CLOTTABLE PROTEIN CONTAINING MAINLY FIBRINOGEN AND FIBRONECTIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 50-90
INN or Proposed INN: Human Thrombin
CAS Number: 9002-04-4
Other descriptive name: HUMAN THROMBIN
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: range
Concentration number: 800-1200

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 4 minutes following randomization

Main Objective: To evaluate the safety and hemostatic effectiveness of EVARREST Fibrin Sealant Patch versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.

Primary end point(s): Proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to initiation of wound closure (latest point in time where EVARREST is visible to confirm hemostasis). Hemostasis is defined as no detectable bleeding at the TBS.

Secondary Objective: Not applicable

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: For first secondary endpoint: 10 minutes. Other endpoints throughout study period.

Secondary end point(s): Proportion of subjects achieving hemostatic success at 10 minutes following randomization (defined as achievement of hemostasis at 10 minutes and no further bleeding requiring re-treatment prior to wound closure);
Absolute time to hemostasis (defined as the absolute time to achieve hemostasis at or after 4 minutes from randomization);
Incidence of re-bleeding events from the TBS during the study follow-up;
Incidence of adverse events;
Incidence of adverse events that are potentially related to thrombotic events

Secondary ID(s)

BIOS-13-005

Source(s) of Monetary Support

Ethicon, A division of Johnson & Johnson Medical Ltd.