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

Adjunct to Hemostasis During Vascular Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04083807
• Other study ID #: BXU529732
• Status: Completed
• Phase: Phase 3
• Start date: July 10, 2019
• Est. completion date: October 22, 2019

Study information

• Verified date: December 2019
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 22, 2019
• Est. primary completion date: October 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adjunct to Hemostasis During Vascular Surgery

Intervention

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.

Procedure:
• Manual compression with surgical gauze pads
Surgical 4x4 inches gauze pads

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Number of participants with intraoperative re-bleeding after hemostasis	Performed on suture line.	Day 0 (intraoperative)
Secondary	Number of participants with postoperative re-bleeding after hemostasis	Performed on suture line. Requires surgical re-exploration.	Day 1 (postoperative)