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

Primary Purpose

Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Spray Fibrin Sealant
Traditional Hemostasis and chest Closure Routine
Sponsored by
Cardiochirurgia E.H.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage focused on measuring Bleeding, Heart Surgery, Reoperation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • European Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TISSEEL

CONTROL

Arm Description

Spray Fibrin Sealant

Traditional hemostasis and chest closure routine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 14, 2015
Last Updated
September 17, 2018
Sponsor
Cardiochirurgia E.H.
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1. Study Identification

Unique Protocol Identification Number
NCT02360800
Brief Title
Trial Comparing Tisseel as an Adjunct to Traditional Hemostasis After Redo Cardiac Surgery
Acronym
RETICO
Official Title
Randomized Prospective Comparison of Tisseel Or Control to Diminish Blood Loss After Redo Redo Cardiac Surgery: the Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
June 3, 2018 (Actual)
Study Completion Date
September 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiochirurgia E.H.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
Keywords
Bleeding, Heart Surgery, Reoperation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TISSEEL
Arm Type
Experimental
Arm Description
Spray Fibrin Sealant
Arm Title
CONTROL
Arm Type
Active Comparator
Arm Description
Traditional hemostasis and chest closure routine
Intervention Type
Procedure
Intervention Name(s)
Spray Fibrin Sealant
Other Intervention Name(s)
TISSEEL
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Traditional Hemostasis and chest Closure Routine
Intervention Description
Routine chest hemostasis and closure protocol (gauzes and inspection till satisfactory according to the surgeon)
Primary Outcome Measure Information:
Title
Bleeding (Amount of blood (ml) collected in chest drainage)
Description
Amount of blood (ml) collected in chest drainage in the first 24 hours after operation
Time Frame
first 24 hours after surgery
Secondary Outcome Measure Information:
Title
Allogeneic blood Sparing (Amount of Allogeneic Blood units (number) transfused in the first 4 days after surgery)
Description
Amount of Allogeneic Blood units (number) transfused in the first 4 days after surgery
Time Frame
4 days after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients undergoing any kind of redo cardiac surgery with ati least one previous sternotomy Exclusion Criteria: None
Facility Information:
Facility Name
European Hospital
City
Rome
State/Province
Lazio
ZIP/Postal Code
00149
Country
Italy

12. IPD Sharing Statement

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

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