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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02360800
Acronym
RETICO
Enrollment
120
Registered
2015-02-11
Start date
2017-02-02
Completion date
2018-09-16
Last updated
2018-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage

Keywords

Bleeding, Heart Surgery, Reoperation

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.

Interventions

PROCEDURESpray 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.

PROCEDURETraditional Hemostasis and chest Closure Routine

Routine chest hemostasis and closure protocol (gauzes and inspection till satisfactory according to the surgeon)

Sponsors

Cardiochirurgia E.H.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Bleeding (Amount of blood (ml) collected in chest drainage)first 24 hours after surgeryAmount of blood (ml) collected in chest drainage in the first 24 hours after operation

Secondary

MeasureTime frameDescription
Allogeneic blood Sparing (Amount of Allogeneic Blood units (number) transfused in the first 4 days after surgery)4 days after surgeryAmount of Allogeneic Blood units (number) transfused in the first 4 days after surgery

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026