Transfusion ReactionsNCT01463345
Blood Conservation in Cardiac Surgery
A study testing Blood transfusion in people with Transfusion Reactions and Post Cardiac Surgery, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
The objective of the study is to examine the safety of two different hemoglobin (Hgb)-based transfusion triggers in patients post cardiac surgery. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Transfusion Reactions, Post Cardiac Surgery
- What is being tested?
- Blood transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to May 2013
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who meet all of the following criteria will be considered for inclusion in this study:
- Subjects scheduled to undergo any of the following cardiac surgeries as part of their routine medical care:
- CABG
- AVR
- MVR
- MV Repair
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- CABG/AVR
- CABG/MVR
- CABG/MV Repair
- Thoracic Aneurysm Repair ± any concomitant cardiac procedure (valve, CABG, etc.)
- Subjects must be > 18 years of age
- No prior history of cardiac surgery.
- Able and willing to give informed consent
Who cannot join
- Subjects who meet any of the following criteria will be excluded from participation in this study:
- Prior history of cardiac surgery
- Patients who do not have sufficient time prior to surgery to give proper informed consent (i.e.: immediate, emergency surgery)
- Patients who are younger than 18 years of age
- Prior history of
- bleeding disorders
Show all 14Show fewer
- symptomatic anemia (i.e. persistent tachycardia, orthostatic hypotension, persistent pressor requirement)
- hereditary/acquired coagulopathy
- platelet defects (e.g.: disseminated intravascular coagulation (DIC), hemophilia, Henoch-Schönlein purpura, hereditary hemorrhagic telangiectasia, thrombocytopenia (ITP, TTP), thrombophilia, Von Willebrand's disease)
- History of leukemia or any other blood related malignancy
- History of liver failure
- Current, or history of, pre-existing medical condition other than current cardiac condition, which in the opinion of the investigator, would place the subject at risk or have the potential to confound interpretation of the study results
- Participation in another clinical trial
- Lack of capacity to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
The objective of the study is to examine the safety of two different hemoglobin (Hgb)-based transfusion triggers in patients post cardiac surgery.
Read the detailed description
Nearly 20% of blood transfusions in the United States are given to in patients undergoing cardiac surgery. Despite the many blood conservation techniques that are available, safe, and efficacious for patients, many of these operations continue to be associated with significant amounts of blood usage. We believe that transfusion protocols which employ specific guidelines for transfusion can decrease blood product usage and improve outcomes for patients undergoing cardiac surgery. Our goal is to demonstrate that a carefully chosen trigger can achieve better outcomes.
Our hypothesis is that a transfusion trigger of Hgb 7.5 g/dl will lead to decreased utilization of blood transfusions and will have many positive effects on the patients post cardiac surgery in addition to substantial cost savings. We will use an evidence based approach to observe the relative safety of a conservative transfusion trigger (7.5 g/dl) as compared to a more liberal trigger (9.0 g/dl). We will also study the effect of blood conservation on the incidence of transfusion-related complications such as transfusion related lung injury (TRALI) and infectious complications as well as length of hospital stay, cost and ventilator time.
- Conditions
- Transfusion Reactions, Post Cardiac Surgery
- Being tested
- Blood transfusion
- Keywords
- Blood conservation, Transfusion, Hemoglobin trigger, Transfusion trigger, Cardiac surgery, Transfusion triggers post cardiac surgery
- Medical subject headings
- Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusionOther
Conservative transfusion arm: Subjects randomized to the conservative transfusion arm will receive transfusions of PRBCs post-surgery only when their Hgb level measures < 7.5 g/dl. Blood products should be given to maintain Hgb levels >7.5 g/dl.
Blood transfusionOther
Liberal transfusion arm: Subjects randomized to the liberal transfusion arm will receive transfusions of PRBCs post-surgery only when their Hgb level measures < 9.0 g/dl. Blood products should be given to maintain Hgb levels > 9.0 g/dl.
| Study group | Role | What they receive |
|---|---|---|
| Conservative Transfusion Arm | Experimental | Subjects in the conservative transfusion arm will receive transfusion only when their hemoglobin levels reach 7.5 g/dl. Receives: Other: Blood transfusion |
| Liberal Transfusion Arm | Active comparator | Subjects in the liberal transfusion arm will receive transfusion only when their hemoglobin levels reach 9.0 g/dl. Receives: Other: Blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the lower hemoglobin transfusion trigger of 7.5 g/dl against the higher hemoglobin transfusion trigger of 9.0 g/dl.
This outcome measure is a simultaneous assessment of the multiple end points duration of pressor use, symptomatic anemia, anemia-associated hypotension within 48 hours post surgery and Hgb recovery by day 4 post-surgery.
Measured: The assessment will last untill day 4 post surgery
Secondary outcomes (1)
Rate of incidence of transfusion related complications between the two randomizations arms.
The comparison will be based on a composite end point consisting of transfusion related lung injury (TRALI) that is ARDS, ventilator time>24 hours, pneumonia; stroke (permanent/transient); MI and renal failure.
Measured: This will be compared during the hospital stay, untill 30 days after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: PI left and closed study at Hackensack went to RUTGERS
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfusion ReactionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers, The State University of New Jersey
- Responsible party
- Sponsor
- Investigators
- Leonard Lee, M.D., Principal investigator, Dr Lee is leaving Hackensack University Medical Center on June 30th, 2012. Effective July 1st, 2012 he will assume his new role as the Chief of Cardiothoracic Surgery Division at the University OF Medicine & Dentistry OFNew Jersey-Robert Wood Johnson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463345
- Sponsor's protocol ID
- Pro00001949
- Status last verified
- Jul 2018
- First submitted
- 27 Oct 2011
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Conservation in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01463345
- Acronym / sponsor ID
- Pro00001949
- Conditions
- Transfusion Reactions, Post Cardiac Surgery
- Keywords
- Blood conservation, Transfusion, Hemoglobin trigger, Transfusion trigger, Cardiac surgery, Transfusion triggers post cardiac surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left and closed study at Hackensack went to RUTGERS
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- Rutgers, The State University of New Jersey
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 1 Nov 2011 (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 objective of the study is to examine the safety of two different hemoglobin (Hgb)-based transfusion triggers in patients post cardiac surgery.
Detailed description
Nearly 20% of blood transfusions in the United States are given to in patients undergoing cardiac surgery. Despite the many blood conservation techniques that are available, safe, and efficacious for patients, many of these operations continue to be associated with significant amounts of blood usage. We believe that transfusion protocols which employ specific guidelines for transfusion can decrease blood product usage and improve outcomes for patients undergoing cardiac surgery. Our goal is to demonstrate that a carefully chosen trigger can achieve better outcomes.
Our hypothesis is that a transfusion trigger of Hgb 7.5 g/dl will lead to decreased utilization of blood transfusions and will have many positive effects on the patients post cardiac surgery in addition to substantial cost savings. We will use an evidence based approach to observe the relative safety of a conservative transfusion trigger (7.5 g/dl) as compared to a more liberal trigger (9.0 g/dl). We will also study the effect of blood conservation on the incidence of transfusion-related complications such as transfusion related lung injury (TRALI) and infectious complications as well as length of hospital stay, cost and ventilator time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative Transfusion Arm | Experimental | Other: Blood transfusionSubjects in the conservative transfusion arm will receive transfusion only when their hemoglobin levels reach 7.5 g/dl. |
| Liberal Transfusion Arm | Active comparator | Other: Blood transfusionSubjects in the liberal transfusion arm will receive transfusion only when their hemoglobin levels reach 9.0 g/dl. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects who meet all of the following criteria will be considered for inclusion in this study:
- Subjects scheduled to undergo any of the following cardiac surgeries as part of their routine medical care:
- Subjects must be > 18 years of age
- No prior history of cardiac surgery.
- Able and willing to give informed consent
Key exclusion criteria (14 listed)
- Subjects who meet any of the following criteria will be excluded from participation in this study:
- Prior history of cardiac surgery
- Patients who do not have sufficient time prior to surgery to give proper informed consent (i.e.: immediate, emergency surgery)
- Patients who are younger than 18 years of age
- Prior history of
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 |
|---|---|---|
| Blood transfusionConservative transfusion arm: Subjects randomized to the conservative transfusion arm will receive transfusions of PRBCs post-surgery only when their Hgb level measures < 7.5 g/dl. Blood products should be given to maintain Hgb levels >7.5 g/dl. | Other | Conservative Transfusion Arm |
| Blood transfusionLiberal transfusion arm: Subjects randomized to the liberal transfusion arm will receive transfusions of PRBCs post-surgery only when their Hgb level measures < 9.0 g/dl. Blood products should be given to maintain Hgb levels > 9.0 g/dl. | Other | Liberal Transfusion Arm |
Primary outcome
Safety of the lower hemoglobin transfusion trigger of 7.5 g/dl against the higher hemoglobin transfusion trigger of 9.0 g/dl.
Time frame: The assessment will last untill day 4 post surgery
This outcome measure is a simultaneous assessment of the multiple end points duration of pressor use, symptomatic anemia, anemia-associated hypotension within 48 hours post surgery and Hgb recovery by day 4 post-surgery.
1 secondary outcome
Rate of incidence of transfusion related complications between the two randomizations arms.
Time frame: This will be compared during the hospital stay, untill 30 days after discharge.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 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.
Leonard Lee, M.D. principal investigator
Dr Lee is leaving Hackensack University Medical Center on June 30th, 2012. Effective July 1st, 2012 he will assume his new role as the Chief of Cardiothoracic Surgery Division at the University OF Medicine & Dentistry OFNew Jersey-Robert Wood Johnson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood transfusion in people with Transfusion Reactions and Post Cardiac Surgery, run by Hackensack Meridian Health 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 13 inclusion and 14 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: withdrawn, as of the sponsor's last update on 24 Jul 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Safety of the lower hemoglobin transfusion trigger of 7.5 g/dl against the higher hemoglobin transfusion trigger of 9.0 g/dl. (time frame: The assessment will last untill day 4 post 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 24 Jul 2018.