Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis

NCT ID: NCT04083807

Last Updated: 2019-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-10
• Study Completion Date: 2019-10-22

Brief Summary

The primary objective of the study is to evaluate the efficacy of TISSEEL Lyo for haemostasis in patients receiving peripheral vascular prosthetic expanded polytetrafluoroethylene (ePTFE) conduits, as compared to a control arm treated with manual compression with surgical gauze pads.

Conditions

Adjunct to Hemostasis During Vascular Surgery

Keywords

haemostasis; tissue glue; tissue sealing; Ilio-femoral bypass; Femoro-femoral bypass; Ilio-popliteal bypass; Femoro-popliteal bypass; Femoro-tibial vessel bypass; Arterio-arterial-bypass; Arteriovenous shunting for dialysis

Study Design

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

Study Groups

TISSEEL Lyo

Applied once intra-operatively to the study suture line using the DUPLOJECT Fibrin Sealant Preparation and Application System.

Group Type: EXPERIMENTAL

TISSEEL Lyo

Intervention Type: BIOLOGICAL

The dose to be applied is governed by variables including the type of surgical intervention, the size of the affected area and the mode of intended application, and the number of applications.. The guideline for sealing surfaces is one package of Tisseel Lyo 2 ml (i.e. 1 ml sealer protein solution plus 1 ml thrombin solution) is sufficient for a surface of at least 10 cm2.

Manual compression with surgical gauze pads

Treated once intraoperatively with manual compression using surgical gauze pads at the study suture line.

Group Type: ACTIVE_COMPARATOR

Manual compression with surgical gauze pads

Intervention Type: PROCEDURE

Surgical 4x4 inches gauze pads

Interventions

TISSEEL Lyo

The dose to be applied is governed by variables including the type of surgical intervention, the size of the affected area and the mode of intended application, and the number of applications.. The guideline for sealing surfaces is one package of Tisseel Lyo 2 ml (i.e. 1 ml sealer protein solution plus 1 ml thrombin solution) is sufficient for a surface of at least 10 cm2.

Intervention Type: BIOLOGICAL

Manual compression with surgical gauze pads

Surgical 4x4 inches gauze pads

Intervention Type: PROCEDURE

Other Intervention Names

Fibrin sealant Vapor Heated, Solvent/Detergent-Treated, with 500 IU/mL Thrombin

Eligibility Criteria

Inclusion Criteria

• Signed informed consent;
• Male or female ≥ 18 ages;
• Patients undergoing primary vascular surgery (i.e., conduit placement with an ePTFE graft), including the following:

1. Arterio-arterial-bypass;

• Ilio-femoral bypass;
• Femoro-femoral bypass;
• Ilio-popliteal bypass;
• Femoro-popliteal bypass;
• Femoro-tibial vessel bypass

2. Arteriovenous shunting for dialysis access in the upper or lower extremity;

Intraoperative inclusion criterion:

• Suture line bleeding eligible for study treatment is present after surgical hemostasis.

Exclusion Criteria

• Concurrent participation in another clinical study treatment with another investigational drug or device within last 30 days;
• Other vascular procedures during the same surgical session;
• Arterio-arterial bypasses with more than two anastomoses;
• Haemoglobin <9.0 g/dL at screening;
• Pregnant or lactating women;
• Congenital or acquired coagulation disorders;
• Prior kidney transplantation;
• Heparin-induced thrombocytopenia;
• Known prior exposure to aprotinin within the last 12 months;
• Known hypersensitivity to aprotinin, heparin, blood products or other components of the investigational product;
• Unwilling to receive blood products.
• Known severe congenital or acquired immunodeficiency;
• Prior radiation therapy to the operating field;
• Severe local inflammation at the operating field;
• Positive results of any of the following the blood tests: HIV, syphilis, hepatitis B, hepatitis C.
• Emergency surgery.
• Alcohol or drug abuse.

• Major intraoperative complications that required resuscitation or deviation from the planned surgical procedure;

• 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

Locations

Baxter Investigational Site

Moscow, , Russia

Baxter Investigational Site

Novosibirsk, , Russia

Baxter Investigational Site

Rostov-on-Don, , Russia

Baxter Investigational Site

Ryazan, , Russia

Baxter Investigational Site

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

BXU529732

Identifier Type: -

Identifier Source: org_study_id