Cardiac DefectNCT02751645
Safety and Efficacy of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients
A study testing Acute Normovolemic hemodilution in people with Cardiac Defect, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The investigators primary objective is to determine if acute normovolemic hemodilution (ANH) for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate post-operative period as compared to usual care. Read more about this study
- Who is it for?
- Ages 6 months to 3 years
- Conditions the study is for
- Cardiac Defect
- What is being tested?
- Acute Normovolemic hemodilution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2016to 31 May 2020
- 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 6 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed signed consent must be obtained by a legally authorized representative.
- Must be undergoing an elective surgical repair or palliation of a cardiac defect with the use of the cardiopulmonary bypass machine.
- Must be clinically stable at the time of evaluation for eligibility and on the day of randomization.
Who cannot join
- Patients who carry a diagnosis of a bleeding disorder.
- Patients who have an abnormal coagulation profile as evidenced by a preoperative coagulation screen.
- Patients who have received a blood transfusion in the preceding 120 days.
- Patients who have a diagnosis of a chromosomal abnormality.
- Patients whose participation in the study is deemed unsafe by their primary care team.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: The Efficacy and Safety of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients
The investigators primary objective is to determine if acute normovolemic hemodilution (ANH) for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate post-operative period as compared to usual care. This study will enroll 24 pediatric heart surgery patients, aged 6 months to 3 years old undergoing either ANH prior to initiating cardiopulmonary bypass or the standard of care procedures for the use of cardiopulmonary bypass.
Read the detailed description
Blood transfusion has been associated with worse outcomes in pediatric cardiac surgical patients. The major complications associated with it include increased blood loss during and after surgery, kidney disease requiring dialysis, abnormal coagulation profile, increased vasopressor use, and increased time spent on the ventilator and in the intensive care unit. One strategy to minimize blood product administration is acute normovolemic hemodilution (ANH). The investigators primary aim is to determine if ANH for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate post-operative period, compared to usual care. The investigators designed a randomized, controlled, open label study that equally assigns 24 pediatric cardiac surgery patients aged 6 months to 3 years into two groups to receive either ANH prior to initiating cardiopulmonary bypass or usual standard of care. Participants in the ANH arm of the study will have 10 ml/kg of blood removed following anesthetic induction. In order to maintain normal circulating volume, the collected blood will be replaced with an equal volume of 5% albumin. All participants will be treated with a standardized protocol aimed at blood conservation including the use of retrograde arterial and antegrade venous perfusion, small circuit size, intraoperative red blood cell salvage, and low hemoglobin targets to trigger transfusion.
- Conditions
- Cardiac Defect
- Being tested
- Acute Normovolemic hemodilution
- Keywords
- Pediatric, Cardiac, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Normovolemic hemodilutionProcedure or surgery
ANH is a technique in which a portion of the patients' own blood is removed before any surgical bleeding occurs. It is stored until the end of the operation, at which point it is returned to the patient.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Control | No intervention | This group will consist of all the participants that receive the standard of care treatment for elective surgical repair or palliation of their cardiac defect with the use of the cardiopulmonary bypass machine. |
| Acute Normovolemic Hemodilution | Experimental | This group will consist of all the participants that receive the acute normovolemic hemodilution prior to their elective surgical repair or palliation of their cardiac defect with the use of the cardiopulmonary bypass machine. Receives: Procedure: Acute Normovolemic hemodilution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of ANH to decrease volume of blood products during surgery and the immediate post-operative period.
This will be measured by comparing the volume (mL/Kg body weight) of any blood products administered peri-operatively between the two groups.
Measured: 2 Days
Secondary outcomes (8)
Kidney function
This will be measured by the change in creatinine on postoperative day 2 from the pre-operative baseline value
Measured: 2 days
Normalization of thromboelastogrpahy (TEG) MA value (maximum amplitude)
This will be measured by thromboelastography (TEG) test following end of cardiopulmonary bypass
Measured: 2 days
Normalization of thromboelastography (TEG) R value (reaction time)
This will be measured by thromboelastography (TEG) test following end of cardiopulmonary bypass
Measured: 2 days
Normalization of thromboelastography (TEG) Alpha Angle value
This will be measured by thromboelastography (TEG) test following end of cardiopulmonary bypass
Measured: 2 days
Final hematocrit, platelet count, PT/PTT on ICU admission
These lab values will be recorded and compared for each group.
Measured: 1 day
Hematocrit and platelet count on post-operative day 1
These lab values will be recorded and compared for each group.
Measured: 1 days
Time to end of vasoactive support in the first 24 hours post-operation.
This value will be recorded and compared for each group.
Measured: 1 days
Duration of mechanical ventilation and ICU stay
This value will be recorded and compared for each group.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start30 Jun 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DefectStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Responsible party
- Principal investigator, Weronika Crescini, MD, Oregon Health and Science University
- Investigators
- Miriam Treggiari, MD, Study director, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751645
- Sponsor's protocol ID
- IRB#: 11949
- Status last verified
- May 2019
- First submitted
- 13 Apr 2016
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: There are no plans to share the data collected during this study.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT02751645
- Acronym / sponsor ID
- IRB#: 11949
- Conditions
- Cardiac Defect
- Keywords
- Pediatric, Cardiac, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 26 Apr 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 investigators primary objective is to determine if acute normovolemic hemodilution (ANH) for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate post-operative period as compared to usual care. This study will enroll 24 pediatric heart surgery patients, aged 6 months to 3 years old undergoing either ANH prior to initiating cardiopulmonary bypass or the standard of care procedures for the use of cardiopulmonary bypass.
Detailed description
Blood transfusion has been associated with worse outcomes in pediatric cardiac surgical patients. The major complications associated with it include increased blood loss during and after surgery, kidney disease requiring dialysis, abnormal coagulation profile, increased vasopressor use, and increased time spent on the ventilator and in the intensive care unit. One strategy to minimize blood product administration is acute normovolemic hemodilution (ANH). The investigators primary aim is to determine if ANH for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate post-operative period, compared to usual care. The investigators designed a randomized, controlled, open label study that equally assigns 24 pediatric cardiac surgery patients aged 6 months to 3 years into two groups to receive either ANH prior to initiating cardiopulmonary bypass or usual standard of care. Participants in the ANH arm of the study will have 10 ml/kg of blood removed following anesthetic induction. In order to maintain normal circulating volume, the collected blood will be replaced with an equal volume of 5% albumin. All participants will be treated with a standardized protocol aimed at blood conservation including the use of retrograde arterial and antegrade venous perfusion, small circuit size, intraoperative red blood cell salvage, and low hemoglobin targets to trigger transfusion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Control | No intervention | –This group will consist of all the participants that receive the standard of care treatment for elective surgical repair or palliation of their cardiac defect with the use of the cardiopulmonary bypass machine. |
| Acute Normovolemic Hemodilution | Experimental | Procedure: Acute Normovolemic hemodilutionThis group will consist of all the participants that receive the acute normovolemic hemodilution prior to their elective surgical repair or palliation of their cardiac defect with the use of the cardiopulmonary bypass machine. |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Informed signed consent must be obtained by a legally authorized representative.
- Must be undergoing an elective surgical repair or palliation of a cardiac defect with the use of the cardiopulmonary bypass machine.
- Must be clinically stable at the time of evaluation for eligibility and on the day of randomization.
Key exclusion criteria (5 listed)
- Patients who carry a diagnosis of a bleeding disorder.
- Patients who have an abnormal coagulation profile as evidenced by a preoperative coagulation screen.
- Patients who have received a blood transfusion in the preceding 120 days.
- Patients who have a diagnosis of a chromosomal abnormality.
- Patients whose participation in the study is deemed unsafe by their primary care team.
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 |
|---|---|---|
| Acute Normovolemic hemodilutionANH is a technique in which a portion of the patients' own blood is removed before any surgical bleeding occurs. It is stored until the end of the operation, at which point it is returned to the patient. | Procedure or surgery | Acute Normovolemic Hemodilution |
Primary outcome
Effectiveness of ANH to decrease volume of blood products during surgery and the immediate post-operative period.
Time frame: 2 Days
This will be measured by comparing the volume (mL/Kg body weight) of any blood products administered peri-operatively between the two groups.
8 secondary outcomes
Kidney function
Time frame: 2 days
Normalization of thromboelastogrpahy (TEG) MA value (maximum amplitude)
Time frame: 2 days
Normalization of thromboelastography (TEG) R value (reaction time)
Time frame: 2 days
Normalization of thromboelastography (TEG) Alpha Angle value
Time frame: 2 days
Final hematocrit, platelet count, PT/PTT on ICU admission
Time frame: 1 day
Hematocrit and platelet count on post-operative day 1
Time frame: 1 days
Time to end of vasoactive support in the first 24 hours post-operation.
Time frame: 1 days
Duration of mechanical ventilation and ICU stay
Time frame: 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Individual participant dataSharing planned: No. There are no plans to share the data collected during this study.
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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.
Miriam Treggiari, MD study director
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Normovolemic hemodilution in people with Cardiac Defect, run by Oregon Health and Science University 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: status not confirmed, as of the sponsor's last update on 16 May 2019. 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?
Results are not available in the source record.
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?
Effectiveness of ANH to decrease volume of blood products during surgery and the immediate post-operative period. (time frame: 2 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 16 May 2019.