HemorrhageRETICONCT02360800
Trial Comparing Tisseel as an Adjunct to Traditional Hemostasis After Redo Cardiac Surgery
A study testing Spray Fibrin Sealant and Traditional Hemostasis and chest Closure Routine in people with Hemorrhage, run by Cardiochirurgia E.H. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Spray Fibrin Sealant and Traditional Hemostasis and chest Closure Routine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2017to 16 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients undergoing any kind of redo cardiac surgery with ati least one previous sternotomy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hemorrhage
- Being tested
- Spray Fibrin Sealant, Traditional Hemostasis and chest Closure Routine
- Keywords
- Bleeding, Heart Surgery, Reoperation
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spray Fibrin SealantProcedure or surgery
Also called TISSEEL
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 or surgery
Routine chest hemostasis and closure protocol (gauzes and inspection till satisfactory according to the surgeon)
| Study group | Role | What they receive |
|---|---|---|
| TISSEEL | Experimental | Spray Fibrin Sealant Receives: Procedure: Spray Fibrin Sealant |
| CONTROL | Active comparator | Traditional hemostasis and chest closure routine Receives: Procedure: Traditional Hemostasis and chest Closure Routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding (Amount of blood (ml) collected in chest drainage)
Amount of blood (ml) collected in chest drainage in the first 24 hours after operation
Measured: 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)
Amount of Allogeneic Blood units (number) transfused in the first 4 days after surgery
Measured: 4 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study start2 Feb 2017
- Primary completion3 Jun 2018
- Study completion16 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiochirurgia E.H.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360800
- Sponsor's protocol ID
- 2015-01
- Acronym
- RETICO
- Status last verified
- Sep 2018
- First submitted
- 14 Jan 2015
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Comparison of Tisseel Or Control to Diminish Blood Loss After Redo Redo Cardiac Surgery: the Study
- ClinicalTrials.gov ID
- NCT02360800
- Acronym / sponsor ID
- RETICO / 2015-01
- Conditions
- Hemorrhage
- Keywords
- Bleeding, Heart Surgery, Reoperation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cardiochirurgia E.H.University, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 3 Jun 2018 (actual)
- Study completion
- 16 Sep 2018 (actual)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TISSEEL | Experimental | Procedure: Spray Fibrin SealantSpray Fibrin Sealant |
| CONTROL | Active comparator | Procedure: Traditional Hemostasis and chest Closure RoutineTraditional hemostasis and chest closure routine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing any kind of redo cardiac surgery with ati least one previous sternotomy
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spray Fibrin SealantAlso: TISSEELBaxter 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. | Procedure or surgery | TISSEEL |
| Traditional Hemostasis and chest Closure RoutineRoutine chest hemostasis and closure protocol (gauzes and inspection till satisfactory according to the surgeon) | Procedure or surgery | CONTROL |
Primary outcome
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
1 secondary outcome
Allogeneic blood Sparing (Amount of Allogeneic Blood units (number) transfused in the first 4 days after surgery)
Time frame: 4 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spray Fibrin Sealant and Traditional Hemostasis and chest Closure Routine in people with Hemorrhage, run by Cardiochirurgia E.H. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding (Amount of blood (ml) collected in chest drainage) (time frame: first 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.