Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04083807 | Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis | PHASE3 | COMPLETED | 104 | — | — | Jul 10, 2019 | Oct 22, 2019 | Dec 6, 2019 | 5 | Russia |
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...