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

Hemorrhage Clinical Trial

— RETICO  

Official title:

Randomized Prospective Comparison of Tisseel Or Control to Diminish Blood Loss After Redo Redo Cardiac Surgery: the Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360800
• Other study ID #: 2015-01
• Status: Completed
• Phase: N/A
• Start date: February 2, 2017
• Est. completion date: September 16, 2018

Study information

• Verified date: September 2018
• Source: Cardiochirurgia E.H.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 16, 2018
• Est. primary completion date: June 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients undergoing any kind of redo cardiac surgery with ati least one previous sternotomy

Exclusion Criteria:

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Procedure:
• Spray Fibrin Sealant
Baxter Tisseel (Fibrin Sealant) is sprayed in the mediastinum at the end of the operation afetr routine chest hemostasis protocol has been completed, right before closing the chest.
• Traditional Hemostasis and chest Closure Routine
Routine chest hemostasis and closure protocol (gauzes and inspection till satisfactory according to the surgeon)

Locations

Country	Name	City	State
Italy	European Hospital	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Cardiochirurgia E.H.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding (Amount of blood (ml) collected in chest drainage)	Amount of blood (ml) collected in chest drainage in the first 24 hours after operation	first 24 hours after surgery
Secondary	Allogeneic blood Sparing (Amount of Allogeneic Blood units (number) transfused in the first 4 days after surgery)	Amount of Allogeneic Blood units (number) transfused in the first 4 days after surgery	4 days after surgery