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

September 17, 2018 updated by: Cardiochirurgia E.H.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00149
        • European Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TISSEEL
Spray Fibrin Sealant
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.
Other Names:
  • TISSEEL
Active Comparator: CONTROL
Traditional hemostasis and chest closure routine
Procedure: Traditional Hemostasis and chest Closure Routine
Routine chest hemostasis and closure protocol (gauzes and inspection till satisfactory according to the surgeon)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
first 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiochirurgia E.H.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2017

Primary Completion (Actual)

June 3, 2018

Study Completion (Actual)

September 16, 2018

Study Registration Dates

First Submitted

January 14, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 11, 2015

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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