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

December 5, 2019 updated by: Baxter Healthcare Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants achieving hemostasis at 4 minutes after treatment
Time Frame: Day 0 (4 minutes post-treatment to closure of surgical wound)
Performed on suture line.
Day 0 (4 minutes post-treatment to closure of surgical wound)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants achieving hemostasis at 6 minutes after treatment
Time Frame: Day 0 (6 minutes post-treatment to closure of surgical wound)
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
Time Frame: Day 0 (10 minutes post-treatment to closure of surgical wound)
Performed on suture line.
Day 0 (10 minutes post-treatment to closure of surgical wound)
Number of participants with intraoperative re-bleeding after hemostasis
Time Frame: Day 0 (intraoperative)
Performed on suture line.
Day 0 (intraoperative)
Number of participants with postoperative re-bleeding after hemostasis
Time Frame: Day 1 (postoperative)
Performed on suture line. Requires surgical re-exploration.
Day 1 (postoperative)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baxter Healthcare Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 22, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 22, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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