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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083807
Recruitment Status : Completed
First Posted : September 10, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation

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.

Condition or disease Intervention/treatment Phase
Adjunct to Hemostasis During Vascular Surgery Biological: TISSEEL Lyo Procedure: Manual compression with surgical gauze pads Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 10, 2019
Actual Primary Completion Date : October 22, 2019
Actual Study Completion Date : October 22, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Thrombin

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 Name: 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Number of participants with intraoperative re-bleeding after hemostasis [ Time Frame: Day 0 (intraoperative) ]
    Performed on suture line.

  4. Number of participants with postoperative re-bleeding after hemostasis [ Time Frame: Day 1 (postoperative) ]
    Performed on suture line. Requires surgical re-exploration.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083807


Locations
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Russian Federation
Baxter Investigational Site
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
Sponsors and Collaborators
Baxter Healthcare Corporation
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Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT04083807    
Other Study ID Numbers: BXU529732
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Baxter Healthcare Corporation:
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:
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Fibrin Tissue Adhesive
Thrombin
Hemostatics
Coagulants