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
Verified date | December 2019 |
Source | Baxter Healthcare Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Baxter Healthcare Corporation |
Russian Federation,
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) |