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OpenTrials
Completed

NCT Number: NCT02360800

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

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.

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Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

European Hospital

Rome, Lazio, 00149, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Spray Fibrin Sealant

Procedure

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.

Other names: TISSEEL

Traditional Hemostasis and chest Closure Routine

Procedure

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

Primary outcomes

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

    Time frame: first 24 hours after surgery

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

Secondary outcomes

  1. Allogeneic blood Sparing (Amount of Allogeneic Blood units (number) transfused in the first 4 days after surgery)

    Time frame: 4 days after surgery

    Amount of Allogeneic Blood units (number) transfused in the first 4 days after surgery

Sponsors and collaborators

Lead sponsor

Cardiochirurgia E.H.

Other

Registry information

Official study title

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

Acronym: RETICO

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 11, 2015
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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