Trials / Completed
CompletedNCT04083807
Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 104 (actual)
- Sponsor
- Baxter Healthcare Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TISSEEL 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. |
| PROCEDURE | Manual compression with surgical gauze pads | Surgical 4x4 inches gauze pads |
Timeline
- Start date
- 2019-07-10
- Primary completion
- 2019-10-22
- Completion
- 2019-10-22
- First posted
- 2019-09-10
- Last updated
- 2019-12-06
Locations
5 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT04083807. Inclusion in this directory is not an endorsement.