Clinical trial NCT04083807: Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adjunct to Hemostasis During Vascular Surgery
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
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2019-09-10
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants achieving hemostasis at 4 minutes after treatment
timeFrame: Day 0 (4 minutes post-treatment to closure of surgical wound)
Secondary outcomes:
measure: Number of participants achieving hemostasis at 6 minutes after treatment
timeFrame: Day 0 (6 minutes post-treatment to closure of surgical wound)
measure: Number of participants achieving hemostasis at 10 minutes after treatment
timeFrame: Day 0 (10 minutes post-treatment to closure of surgical wound)
measure: Number of participants with intraoperative re-bleeding after hemostasis
timeFrame: Day 0 (intraoperative)
measure: Number of participants with postoperative re-bleeding after hemostasis
timeFrame: Day 1 (postoperative)
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Baxter Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Baxter Investigational Site
city: Rostov-on-Don
country: Russian Federation
facility: Baxter Investigational Site
city: Ryazan
country: Russian Federation
facility: Baxter Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Baxter Investigational Site
Study officials:
References: