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Trial Comparing Tisseel as an Adjunct to Traditional Hemostasis After Redo Cardiac Surgery

Not Applicable
Completed
Conditions
Hemorrhage
Interventions
Procedure: Traditional Hemostasis and chest Closure Routine
Procedure: 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
Inclusion Criteria
  • All patients undergoing any kind of redo cardiac surgery with ati least one previous sternotomy
Exclusion Criteria
  • None

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CONTROLTraditional Hemostasis and chest Closure RoutineTraditional hemostasis and chest closure routine
TISSEELSpray Fibrin SealantSpray Fibrin Sealant
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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

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