NCT04083807View on ClinicalTrials.gov

Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis

PHASE3CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

July 10, 2019

Primary Completion Date

October 22, 2019

Study Completion Date

October 22, 2019

Conditions
Adjunct to Hemostasis During Vascular Surgery
Interventions
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

Trial Locations (5)

Unknown

Baxter Investigational Site, Moscow

Baxter Investigational Site, Novosibirsk

Baxter Investigational Site, Rostov-on-Don

Baxter Investigational Site, Ryazan

Baxter Investigational Site, Saint Petersburg

All Listed Sponsors
lead

Baxter Healthcare Corporation

INDUSTRY

NCT04083807 - Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis | Biotech Hunter | Biotech Hunter