Impaired Oxygen DeliveryNCT01484886
Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery
A study testing Red blood cell transfusion in people with Impaired Oxygen Delivery and Congenital Heart Disease, run by University of Rochester at 1 site in United States.
Trial summary
In neonates and infants </= 10 kg following cardiac surgery for congenital heart disease a more restrictive red blood cell (RBC) transfusion strategy will be as effective as, and possibly superior to, a liberal RBC strategy. Read more about this study
- Who is it for?
- Ages Up to 7 months
- Conditions the study is for
- Impaired Oxygen Delivery, Congenital Heart Disease
- What is being tested?
- Red blood cell transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Sep 2014
- 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 Up to 7 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children </= 6 months of age with congenital cardiac disease undergoing cardiac surgery with cardiopulmonary bypass.
Who cannot join
- presence of a known bleeding disorder or coagulopathy.
- age > 6 months,
- lack of informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Prospective Randomized Controlled Clinical Trial Comparing a Restrictive Versus Liberal Transfusion Strategy in Neonates and Infants Undergoing Surgery for Congenital Heart Disease
In neonates and infants </= 10 kg following cardiac surgery for congenital heart disease a more restrictive red blood cell (RBC) transfusion strategy will be as effective as, and possibly superior to, a liberal RBC strategy. Allowing lower hemoglobin concentration will not affect the cardiac or pulmonary status of the patient.
- Conditions
- Impaired Oxygen Delivery, Congenital Heart Disease
- Being tested
- Red blood cell transfusion
- Keywords
- Hemoglobin, Congenital heart disease, Cardiac surgery, Red blood cell transfusion, Number of red blood cell transfusions
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red blood cell transfusionOther
10cc/kg weight RBC transfusion as needed according to hemoglobin level
Red blood cell transfusionOther
10cc/kg body weight RBC will be transfused for hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.
| Study group | Role | What they receive |
|---|---|---|
| Restrictive transfusion strategy | Experimental | RBC will be transfused if the hemoglobin level falls below 7 for bi-ventricular repairs and under 9.0 for single ventricle palliations. Receives: Other: Red blood cell transfusion |
| Liberal RBC transfusion strategy | Experimental | RBCs will be transfused for Hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations. Receives: Other: Red blood cell transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen utilization derived from the arterio-venous oxygen difference.
Arterial and venous oxygen saturations will be measured every four hours x 48-72 hours and will be used to calculate arterio-venous oxygen content differences.
Measured: 3 days
Secondary outcomes (1)
volume of RBC transfused
The total numbers of RBC transfusions given during the immediate post-op period (1st 7 days) will be compared between groups.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Oxygen DeliveryStudies 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
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jill cholette, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484886
- Sponsor's protocol ID
- 38569
- Status last verified
- Sep 2014
- First submitted
- 12 Nov 2011
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Clinical Trial Comparing a Restrictive Versus Liberal Transfusion Strategy in Neonates and Infants Undergoing Surgery for Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01484886
- Acronym / sponsor ID
- 38569
- Conditions
- Impaired Oxygen Delivery, Congenital Heart Disease
- Keywords
- Hemoglobin, Congenital heart disease, Cardiac surgery, Red blood cell transfusion, Number of red blood cell transfusions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 2 Dec 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.
In neonates and infants </= 10 kg following cardiac surgery for congenital heart disease a more restrictive red blood cell (RBC) transfusion strategy will be as effective as, and possibly superior to, a liberal RBC strategy. Allowing lower hemoglobin concentration will not affect the cardiac or pulmonary status of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restrictive transfusion strategy | Experimental | Other: Red blood cell transfusionRBC will be transfused if the hemoglobin level falls below 7 for bi-ventricular repairs and under 9.0 for single ventricle palliations. |
| Liberal RBC transfusion strategy | Experimental | Other: Red blood cell transfusionRBCs will be transfused for Hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations. |
Who may qualify
- Ages
- Up to 7 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children </= 6 months of age with congenital cardiac disease undergoing cardiac surgery with cardiopulmonary bypass.
Key exclusion criteria (3 listed)
- presence of a known bleeding disorder or coagulopathy.
- age > 6 months,
- lack of informed consent.
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 |
|---|---|---|
| Red blood cell transfusion10cc/kg weight RBC transfusion as needed according to hemoglobin level | Other | Liberal RBC transfusion strategy, Restrictive transfusion strategy |
| Red blood cell transfusion10cc/kg body weight RBC will be transfused for hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations. | Other | Liberal RBC transfusion strategy |
Primary outcome
oxygen utilization derived from the arterio-venous oxygen difference.
Time frame: 3 days
Arterial and venous oxygen saturations will be measured every four hours x 48-72 hours and will be used to calculate arterio-venous oxygen content differences.
1 secondary outcome
volume of RBC transfused
Time frame: 7 days
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 5 Sep 2014.
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 Red blood cell transfusion in people with Impaired Oxygen Delivery and Congenital Heart Disease, run by University of Rochester 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 1 inclusion and 3 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 5 Sep 2014. 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?
oxygen utilization derived from the arterio-venous oxygen difference. (time frame: 3 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 5 Sep 2014.