Retained Blood SyndromeNCT02682849
Active Clearance Technology (ACT) Registry
An observational study of Retained Blood Syndrome, run by John M. Stulak at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of the PleuraFlow® Active Clearance Technology™ (ACT) System in the management of blood evacuation after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retained Blood Syndrome
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2016to Mar 2020
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The control arm consists of a cohort of matched cardiac surgery patients with data entered over the preceding 12 to 24-month period. The site will consecutively enroll a cohort of cardiac surgery patients in the treatment arm.
Who may be able to join
- Male or Female subjects 18 years of age or older who received a PleuraFlow System following heart surgery.
- Patient undergoing cardiac surgery via sternotomy
Who cannot join
- Robotic surgery
- Any access via thoracotomy
- Any condition deemed inappropriate for inclusion by the investigators.
- Intolerance to implantable silicone materials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Retained-Blood Outcomes With Active Clearance Technology- The ACT Registry
The purpose of this study is to evaluate the effectiveness of the PleuraFlow® Active Clearance Technology™ (ACT) System in the management of blood evacuation after cardiac surgery.
- Conditions
- Retained Blood Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | Not described | |
| Prospective PleuralFlow cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of interventions to Treat Retained Blood Syndrome
Retained Blood Syndrome (RBS) is defined by a composite endpoint of specific reoperation for bleeding, pericardial effusion, and hemothorax.
Measured: Discharge from operating room for index-surgery through hospital discharge - approximate 30 days
Secondary outcomes (2)
Number of episodes of new on set of post operative atrial fibrillations (POAS)
Measured: 30 day
Number of readmissions for any diagnosis of RBS or POAS re-occurrences
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study start10 May 2016
- Primary completionMay 2018
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retained Blood SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 500 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- John M. Stulak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John M. Stulak, Mayo Clinic
- Investigators
- John Stulak, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682849
- Sponsor's protocol ID
- 15-006388
- Status last verified
- Oct 2020
- First submitted
- 11 Feb 2016
- Last updated
- 29 Oct 2020
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Retained-Blood Outcomes With Active Clearance Technology- The ACT Registry
- ClinicalTrials.gov ID
- NCT02682849
- Acronym / sponsor ID
- 15-006388
- Conditions
- Retained Blood Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- John M. StulakUniversity, hospital or other
- Study start
- 10 May 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 15 Feb 2016 (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.
The purpose of this study is to evaluate the effectiveness of the PleuraFlow® Active Clearance Technology™ (ACT) System in the management of blood evacuation after cardiac surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | – |
| Prospective PleuralFlow cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The control arm consists of a cohort of matched cardiac surgery patients with data entered over the preceding 12 to 24-month period. The site will consecutively enroll a cohort of cardiac surgery patients in the treatment arm.
Key inclusion criteria (2 listed)
- Male or Female subjects 18 years of age or older who received a PleuraFlow System following heart surgery.
- Patient undergoing cardiac surgery via sternotomy
Key exclusion criteria (4 listed)
- Robotic surgery
- Any access via thoracotomy
- Any condition deemed inappropriate for inclusion by the investigators.
- Intolerance to implantable silicone materials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of interventions to Treat Retained Blood Syndrome
Time frame: Discharge from operating room for index-surgery through hospital discharge - approximate 30 days
Retained Blood Syndrome (RBS) is defined by a composite endpoint of specific reoperation for bleeding, pericardial effusion, and hemothorax.
2 secondary outcomes
Number of episodes of new on set of post operative atrial fibrillations (POAS)
Time frame: 30 day
Number of readmissions for any diagnosis of RBS or POAS re-occurrences
Time frame: 30 day
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 29 Oct 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Retained Blood Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
John Stulak, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retained Blood Syndrome, run by John M. Stulak at 1 site in United States.
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 2 inclusion and 4 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 29 Oct 2020. 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 United States. 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?
Number of interventions to Treat Retained Blood Syndrome (time frame: Discharge from operating room for index-surgery through hospital discharge - approximate 30 days). 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 29 Oct 2020.