NCT02360800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
2 years until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

1.3 years

First QC Date

January 14, 2015

Last Update Submit

September 17, 2018

Conditions

Hemorrhage

Keywords

BleedingHeart SurgeryReoperation

Outcome Measures

Primary Outcomes (1)

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

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

    first 24 hours after surgery

Secondary Outcomes (1)

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

    4 days after surgery

Study Arms (2)

TISSEEL

EXPERIMENTAL

Spray Fibrin Sealant

Procedure: Spray Fibrin Sealant

CONTROL

ACTIVE COMPARATOR

Traditional hemostasis and chest closure routine

Procedure: Traditional Hemostasis and chest Closure Routine

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.

Also known as: TISSEEL
TISSEEL
Traditional Hemostasis and chest Closure RoutinePROCEDURE

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

CONTROL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Hospital

Rome, Lazio, 00149, Italy

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2015

First Posted

February 11, 2015

Study Start

February 2, 2017

Primary Completion

June 3, 2018

Study Completion

September 16, 2018

Last Updated

September 18, 2018

Record last verified: 2018-09

Locations

IT(1)