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

Phase 3

Completed

• Conditions: Adjunct to Hemostasis During Vascular Surgery
• Interventions: Procedure: Manual compression with surgical gauze pads; Biological: TISSEEL Lyo

• Registration Number: NCT04083807
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-10
• Study First Submitted: 2019-08-23
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-10
• Primary Completion: 2019-10-22
• Study Completion: 2019-10-22
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-05
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual compression with surgical gauze pads	Manual compression with surgical gauze pads	Treated once intraoperatively with manual compression using surgical gauze pads at the study suture line.
TISSEEL Lyo	TISSEEL Lyo	Applied once intra-operatively to the study suture line using the DUPLOJECT Fibrin Sealant Preparation and Application System.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Baxter Investigational Site; 🇷🇺 Saint Petersburg, Russian Federation