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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
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.
Surgical 4x4 inches gauze pads
Baxter Investigational Site
Moscow, Russia
Baxter Investigational Site
Novosibirsk, Russia
Baxter Investigational Site
Rostov-on-Don, Russia
Baxter Investigational Site
Ryazan, Russia
Baxter Investigational Site
Number of participants achieving hemostasis at 4 minutes after treatment
Performed on suture line.
Time frame: Day 0 (4 minutes post-treatment to closure of surgical wound)
Number of participants achieving hemostasis at 6 minutes after treatment
Performed on suture line.
Time frame: 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.
Time frame: Day 0 (10 minutes post-treatment to closure of surgical wound)
Number of participants with intraoperative re-bleeding after hemostasis
Performed on suture line.
Time frame: Day 0 (intraoperative)
Number of participants with postoperative re-bleeding after hemostasis
Performed on suture line. Requires surgical re-exploration.
Time frame: Day 1 (postoperative)
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Saint Petersburg, Russia