Congenital Heart DiseasePhase 2NCT00350220
Transfusion Strategies in Pediatric Cardiothoracic Surgery
A Phase 2 study testing transfusion strategy and Low Hb transfusion group in people with Congenital Heart Disease, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to determine the best red blood cell(hemoglobin) level for infants and children following surgical repair of particular heart defects. These children often receive red blood cell transfusions after surgery, but what the best hemoglobin level is for them remains unknown. Read more about this study
- Who is it for?
- Ages 4 months to 7 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- transfusion strategy and Low Hb transfusion group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Sep 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 4 months to 6.99 years of age
- surgical candidates for cavopulmonary connection
- English speaking
Who cannot join
- presence of known bleeding disorder
- presence of known coagulopathy
- age < 4 months
- age > 7 years
- non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Controlled Clinical Trial Comparing Two Transfusion Strategies in Pediatric Patients Undergoing Cavopulmonary Connection.
The purpose of this study is to determine the best red blood cell(hemoglobin) level for infants and children following surgical repair of particular heart defects. These children often receive red blood cell transfusions after surgery, but what the best hemoglobin level is for them remains unknown.
Read the detailed description
Objective: To compare mean post-operative arterial lactate levels, oxygen utilization, and outcome measures in pediatric patients undergoing cavopulmonary connection managed with two different red blood cell transfusion strategies.
Methods: We propose a prospective, randomized clinical trial of sixty-six pediatric patients with cyanotic, complex congenital cardiac disease undergoing cavopulmonary connection as their operative repair. Thirty-three patients will be randomly assigned to a low Hb strategy of transfusion, in which red cells are transfused if the hemoglobin concentration falls below 9.0 g/dL, and hemoglobin concentrations are maintained about 8.5 g/dL. Thirty-three additional patients will be randomly assigned to the high Hb transfusion strategy, where red cells are transfused if the hemoglobin concentration falls below 13.0 g/dL, and hemoglobin concentrations are maintained about 12.5 g/dL. The primary endpoint will be comparison of mean arterial lactate levels from 8 to 72 hours post-operatively. The secondary endpoints will be oxygen utilization reflected by the arterio-venous oxygen difference (AV-difference) and arterio-cerebral oxygen difference (AC-difference). Measures of oxygen utilization will be derived from arterial oxygen saturation (SaO2), mixed venous oxygen saturation (SvO2), and cerebral oxygen saturation (ScO2) collected at various time points throughout the study. Tertiary outcome measures will be length of mechanical ventilation, length of oxygen use and of vasoactive agent administration, length pediatric cardiac intensive care unit (PCICU) admission, volume of blood transfused, and mortality. Data from each group will be compared using analysis of variance to assess for the presence of a difference between the two transfusion strategies. If a significant difference between the two groups exists, T-tests will be performed to compare data points between each group to assess for a significant difference.
Hypothesis: A more restrictive (low Hb) strategy of red cell transfusion will be as effective as, and possibly superior to, the historical (high Hb) approach. Allowing a lower Hb concentration will decrease RBC donor exposure and may decrease the known complications of RBC transfusions. We postulate that no significant difference will exist between the two transfusion groups in regards to hemodynamic and cardiopulmonary status (as evidenced by mean lactate levels) and oxygen utilization.
- Conditions
- Congenital Heart Disease
- Being tested
- transfusion strategy, Low Hb transfusion group
- Keywords
- Single ventricle, Bidirectional Glenn, Fontan, Congenital cardiac disease, Red blood cell transfusion, oxygen utilization, lactate level, hemoglobin level
- Medical subject headings
- Heart Defects, Congenital, Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transfusion strategyOther
For the High Hb group; transfusions will be given to keep the Hb >13.0 g/dl
Low Hb transfusion groupOther
RBCs will not be transfused unless the Hb < 9.0 g/dl
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | High Hemoglobin group; goal Hb >13g/dl. 10cc/kg RBCs are transfused for any hemoglobin value under 13g/dl regardless whether clinical indication for transfusion exists. Receives: Other: transfusion strategy |
| 2 | Active comparator | Low Hb transfusion group; goal to not transfuse unless the Hb <9.0 g/dl. 10cc/kg RBCs are transfused only if the Hemoglobin is under 9.0g/dl and clinical indications for transfusion exist. Receives: Other: Low Hb transfusion group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Lactate Level
Mean arterial lactate for the first 48 hours post-op.
Measured: 48 hours
Peak Arterial Lactate Level
Peak arterial lactate level for the 48 hour post-op study period.
Measured: 48 hours
Secondary outcomes (6)
Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period.
Measured: 3 days
Length of Mechanical Ventilation
Measured: 3 days
Length of Oxygen Use
Measured: 3 days
Length of Vasoactive Agent Administration
Measured: 3 days
Volume of Blood Transfused
Measured: 3 days
Mortality Before Hospital Discharge
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- Investigators
- Jill M Cholette, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350220
- Sponsor's protocol ID
- 12408
- Status last verified
- May 2015
- First submitted
- 5 Jul 2006
- Last updated
- 26 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
PubMed 41114449
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Clinical Trial Comparing Two Transfusion Strategies in Pediatric Patients Undergoing Cavopulmonary Connection.
- ClinicalTrials.gov ID
- NCT00350220
- Acronym / sponsor ID
- 12408
- Conditions
- Congenital Heart Disease
- Keywords
- Single ventricle, Bidirectional Glenn, Fontan, Congenital cardiac disease, Red blood cell transfusion, oxygen utilization, lactate level, hemoglobin level
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 10 Jul 2006 (estimated)
- Results
- Posted 25 Feb 2010
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 determine the best red blood cell(hemoglobin) level for infants and children following surgical repair of particular heart defects. These children often receive red blood cell transfusions after surgery, but what the best hemoglobin level is for them remains unknown.
Detailed description
Objective: To compare mean post-operative arterial lactate levels, oxygen utilization, and outcome measures in pediatric patients undergoing cavopulmonary connection managed with two different red blood cell transfusion strategies.
Methods: We propose a prospective, randomized clinical trial of sixty-six pediatric patients with cyanotic, complex congenital cardiac disease undergoing cavopulmonary connection as their operative repair. Thirty-three patients will be randomly assigned to a low Hb strategy of transfusion, in which red cells are transfused if the hemoglobin concentration falls below 9.0 g/dL, and hemoglobin concentrations are maintained about 8.5 g/dL. Thirty-three additional patients will be randomly assigned to the high Hb transfusion strategy, where red cells are transfused if the hemoglobin concentration falls below 13.0 g/dL, and hemoglobin concentrations are maintained about 12.5 g/dL. The primary endpoint will be comparison of mean arterial lactate levels from 8 to 72 hours post-operatively. The secondary endpoints will be oxygen utilization reflected by the arterio-venous oxygen difference (AV-difference) and arterio-cerebral oxygen difference (AC-difference). Measures of oxygen utilization will be derived from arterial oxygen saturation (SaO2), mixed venous oxygen saturation (SvO2), and cerebral oxygen saturation (ScO2) collected at various time points throughout the study. Tertiary outcome measures will be length of mechanical ventilation, length of oxygen use and of vasoactive agent administration, length pediatric cardiac intensive care unit (PCICU) admission, volume of blood transfused, and mortality. Data from each group will be compared using analysis of variance to assess for the presence of a difference between the two transfusion strategies. If a significant difference between the two groups exists, T-tests will be performed to compare data points between each group to assess for a significant difference.
Hypothesis: A more restrictive (low Hb) strategy of red cell transfusion will be as effective as, and possibly superior to, the historical (high Hb) approach. Allowing a lower Hb concentration will decrease RBC donor exposure and may decrease the known complications of RBC transfusions. We postulate that no significant difference will exist between the two transfusion groups in regards to hemodynamic and cardiopulmonary status (as evidenced by mean lactate levels) and oxygen utilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: transfusion strategyHigh Hemoglobin group; goal Hb >13g/dl. 10cc/kg RBCs are transfused for any hemoglobin value under 13g/dl regardless whether clinical indication for transfusion exists. |
| 2 | Active comparator | Other: Low Hb transfusion groupLow Hb transfusion group; goal to not transfuse unless the Hb <9.0 g/dl. 10cc/kg RBCs are transfused only if the Hemoglobin is under 9.0g/dl and clinical indications for transfusion exist. |
Who may qualify
- Ages
- 4 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 4 months to 6.99 years of age
- surgical candidates for cavopulmonary connection
- English speaking
Key exclusion criteria (5 listed)
- presence of known bleeding disorder
- presence of known coagulopathy
- age < 4 months
- age > 7 years
- non-English speaking
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 |
|---|---|---|
| transfusion strategyFor the High Hb group; transfusions will be given to keep the Hb >13.0 g/dl | Other | 1 |
| Low Hb transfusion groupRBCs will not be transfused unless the Hb < 9.0 g/dl | Other | 2 |
Primary outcome
Mean Arterial Lactate Level
Time frame: 48 hours
Mean arterial lactate for the first 48 hours post-op.
Peak Arterial Lactate Level
Time frame: 48 hours
Peak arterial lactate level for the 48 hour post-op study period.
6 secondary outcomes
Oxygen Utilization During the 8 Hour to 72 Hours Post-operative Period.
Time frame: 3 days
Length of Mechanical Ventilation
Time frame: 3 days
Length of Oxygen Use
Time frame: 3 days
Length of Vasoactive Agent Administration
Time frame: 3 days
Volume of Blood Transfused
Time frame: 3 days
Mortality Before Hospital Discharge
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41114449Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
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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.
Jill M Cholette, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing transfusion strategy and Low Hb transfusion group in people with 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 3 inclusion and 5 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 26 Jun 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Arterial Lactate Level (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00350220, which also lists 1 linked publication.
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 26 Jun 2015.