Trial Comparing Tisseel as an Adjunct to Traditional Hemostasis After Redo Cardiac Surgery
- Conditions
- Hemorrhage
- Interventions
- Procedure: Traditional Hemostasis and chest Closure RoutineProcedure: Spray Fibrin Sealant
- Registration Number
- NCT02360800
- Lead Sponsor
- Cardiochirurgia E.H.
- Brief Summary
Bleeding after redo cardiac surgery is a common, unresolved and consequences-heavy event as per present day. Tisseel (Baxter inc) sprayed on the already hemostased mediastinum jut before closing seems a promising technique to radically diminish bleeding.
This study aims to verify this efficacy volume in chest drains) and possibly the consensual blood transfusion lessening.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- All patients undergoing any kind of redo cardiac surgery with ati least one previous sternotomy
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CONTROL Traditional Hemostasis and chest Closure Routine Traditional hemostasis and chest closure routine TISSEEL Spray Fibrin Sealant Spray Fibrin Sealant
- Primary Outcome Measures
Name Time Method Bleeding (Amount of blood (ml) collected in chest drainage) first 24 hours after surgery Amount of blood (ml) collected in chest drainage in the first 24 hours after operation
- Secondary Outcome Measures
Name Time Method Allogeneic blood Sparing (Amount of Allogeneic Blood units (number) transfused in the first 4 days after surgery) 4 days after surgery Amount of Allogeneic Blood units (number) transfused in the first 4 days after surgery
Trial Locations
- Locations (1)
European Hospital
🇮🇹Rome, Lazio, Italy