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

Cardiochirurgia E.H.120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Hemorrhage

Interventions

Spray Fibrin SealantPROCEDURE

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 RoutinePROCEDURE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * All patients undergoing any kind of redo cardiac surgery with ati least one previous sternotomy Exclusion Criteria: * None

Locations (1)

European Hospital

Rome, Lazio, Italy

Outcomes

Primary Outcomes

Bleeding (Amount of blood (ml) collected in chest drainage)

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

Time frame: first 24 hours after surgery

Secondary Outcomes

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

Time frame: 4 days after surgery

Data from ClinicalTrials.gov

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