Adjunct to Hemostasis During Vascular Surgery
Conditions
Keywords
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
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.
Interventions
BIOLOGICALTISSEEL 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.
Surgical 4x4 inches gauze pads
Sponsors
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| Number of participants with postoperative re-bleeding after hemostasis | Day 1 (postoperative) | Performed on suture line. Requires surgical re-exploration. |
Countries
Russia
Outcome results
None listed