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

A Randomised Controlled Multicenter Single-blinded Phase III Study to Evaluate the Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis During Vascular Surgery

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.

Study Overview

• Status: Completed
• Conditions: Adjunct to Hemostasis During Vascular Surgery
• Intervention / Treatment: Biological: TISSEEL Lyo; Procedure: Manual compression with surgical gauze pads

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Baxter Investigational SIte
  • Novosibirsk, Russian Federation
    • Baxter Investigational SIte
  • Rostov-on-Don, Russian Federation
    • Baxter Investigational SIte
  • Ryazan, Russian Federation
    • Baxter Investigational SIte
  • Saint Petersburg, Russian Federation
    • Baxter Investigational SIte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Intraoperative exclusion criteria:

• Major intraoperative complications that required resuscitation or deviation from the planned surgical procedure;
• Intraoperative change in planned surgical procedure, which resulted in patient no longer meeting preoperative inclusion criteria or having preoperative exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TISSEEL Lyo; Applied once intra-operatively to the study suture line using the DUPLOJECT Fibrin Sealant Preparation and Application System.	Biological: 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.; Other Names: Fibrin sealant Vapor Heated, Solvent/Detergent-Treated, with 500 IU/mL Thrombin
Active Comparator: Manual compression with surgical gauze pads; Treated once intraoperatively with manual compression using surgical gauze pads at the study suture line.	Procedure: Manual compression with surgical gauze pads; Surgical 4x4 inches gauze pads

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants achieving hemostasis at 4 minutes after treatment	Performed on suture line.	Day 0 (4 minutes post-treatment to closure of surgical wound)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants achieving hemostasis at 6 minutes after treatment	Performed on suture line.	Day 0 (6 minutes post-treatment to closure of surgical wound)
Number of participants achieving hemostasis at 10 minutes after treatment	Performed on suture line.	Day 0 (10 minutes post-treatment to closure of surgical wound)
Number of participants with intraoperative re-bleeding after hemostasis	Performed on suture line.	Day 0 (intraoperative)
Number of participants with postoperative re-bleeding after hemostasis	Performed on suture line. Requires surgical re-exploration.	Day 1 (postoperative)

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2019
• Primary Completion (Actual): October 22, 2019
• Study Completion (Actual): October 22, 2019

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Hemostatics; Coagulants; Fibrin Tissue Adhesive; Thrombin
• Other Study ID Numbers: BXU529732

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No