Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TISSEEL Lyo · 1 trial · 1 indication
Performed on suture line.
| Arm | Type | Description |
|---|---|---|
| TISSEEL Lyo | EXPERIMENTAL | Applied once intra-operatively to the study suture line using the DUPLOJECT Fibrin Sealant Preparation and Application System. |
| Manual compression with surgical gauze pads | ACTIVE_COMPARATOR | Treated once intraoperatively with manual compression using surgical gauze pads at the study suture line. |
| Name | Type | Description |
|---|---|---|
| TISSEEL Lyo | BIOLOGICAL | 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. |
| Manual compression with surgical gauze pads | PROCEDURE | Surgical 4x4 inches gauze pads |
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-pop...
TISSEEL Lyo is used as an adjunct to hemostasis during vascular surgery. It is a fibrin sealant that helps control bleeding when applied to surgical sites. The drug is being developed by Baxter International Inc. and is currently in Phase 3 clinical development for this indication.
TISSEEL Lyo is a monoclonal antibody, though its specific molecular target is not disclosed. It is designed to act as an adjunct to hemostasis, meaning it helps promote blood clotting to reduce bleeding during vascular surgery. The drug is administered locally to the surgical site to achieve this effect.
TISSEEL Lyo is developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker symbol BAX. Baxter is responsible for the clinical development and manufacturing of this investigational product, which is being studied for use as an adjunct to hemostasis during vascular surgery.
TISSEEL Lyo is in Phase 3 clinical development. It is an investigational product and has not yet been approved by regulatory authorities. The Phase 3 trial for this drug has been completed, and the results will inform whether Baxter can proceed with seeking regulatory approval for the vascular surgery indication.
TISSEEL Lyo has been studied in one completed Phase 3 clinical trial, identified by the identifier NCT04083807. This trial, titled "Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis," enrolled 104 participants in Russia. The study was active-controlled and randomized, comparing TISSEEL Lyo to manual compression.
TISSEEL Lyo is a specific formulation of a fibrin sealant developed by Baxter International Inc. It is designed to be used as an adjunct to hemostasis during vascular surgery. While other fibrin sealants exist, TISSEEL Lyo is a distinct product being evaluated in clinical trials for this particular surgical application.