Congenital Heart DiseasePBUFNCT03576534

Pre Bypass Ultrafiltration (PBUF) in Children Requiring Cardiopulmonary Bypass

A study testing Use of prebypass ultrafiltration (PBUF) in people with Congenital Heart Disease, run by Boston Children's Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Newborn babies and children with congenital heart defects who need heart surgery need to be placed on the heart-lung machine for heart surgery. In order to use the heart-lung machine, the investigators have to use blood and other fluids to fill the tubing. Read more about this study

Who is it for?: Ages 1 day to 1 year
Conditions the study is for: Congenital Heart Disease
What is being tested?: Use of prebypass ultrafiltration (PBUF)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: 3 Oct 2019to 13 Sep 2021
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 1 day to 1 year
All sexes
No healthy volunteers
Child

Who may be able to join

All patients < 8 kilograms and < 1 year (to ensure that all patients receive steroids at initiation of CPB) undergoing an index cardiac operation for that hospitalization (using a single PBUF protocol)

Who cannot join

Patients undergoing repeat cardiac surgery within the same admission
Patients undergoing transplants as their index surgery
Patients undergoing Ventricular assist device implantation as their index surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston Children's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Pre Bypass Ultrafiltration (PBUF) Improves Intraoperative Glucose, Sodium, Potassium and Lactate Levels in Children Requiring Cardiopulmonary Bypass

Newborn babies and children with congenital heart defects who need heart surgery need to be placed on the heart-lung machine for heart surgery.

In order to use the heart-lung machine, the investigators have to use blood and other fluids to fill the tubing. During the operation, ultrafiltration is carried out as standard of care to remove extra fluid. Modified ultrafiltration is also performed after surgery. In this study, the investigators are looking to use the filter additionally before surgery. Using the pre bypass filtration before the subject is placed on the heart-lung machine will allow the investigators to better normalize electrolytes in the blood/fluid mixture used in the heart lung machine. This technique is called pre-bypass ultrafiltration, or PBUF (pronounced "P" Buff).

The investigators are conducting a study to see if using PBUF to better normalize electrolytes in the blood will make a difference. The investigators have been adding fluids to prime the heart-lung machine in two different ways. The investigators believe both methods are safe and acceptable but hypothesize that there may be subtle differences in electrolytes and fluid status when one technique is used as opposed to the other. The investigators believe that neither technique introduces risk since both are currently used in practice. The standard method adds blood to the heart-lung machine. The alternate method adds blood to the heart-lung machine and then additional fluid is added and removed to more normalize the electrolytes. The investigators plan to randomized subjects undergoing heart surgery to receive the standard priming method versus PBUF to determine if there is any difference in outcomes. Laboratory and clinical data collected as part of clinical care will be used to determine difference sin outcomes. There will be no additional blood taken for this study.

There are no known risks to PBUF. The benefits include helping investigators determine if PBUF does or does not make a difference to how subjects recover after surgery. The investigators believe that providing more normal blood values will either improve the subjects' outcome or have no benefit. The investigators do not anticipate increased risks.

Given COVID -19 restrictions, the study is on hold.

Read the detailed description

Research question: Can PBUF provide more physiologic values for glucose, sodium, potassium and lactate throughout the cardiopulmonary bypass period without an increased incidence of adverse events?

Background: The values for glucose, sodium, potassium and lactate in blood primes for subjects weighing less than 8 kg are known to be non-physiologic. The process of priming the cardiopulmonary bypass circuit is not standardized across institutions and there are several methods used to correct for known prime value issues. The investigators documented the prime values for 20 subjects weighing less than 8 kg and then performed pre-bypass ultrafiltration (PBUF) on the prime for those same circuits to achieve more physiologic prime values. The investigators were cautious not to implement too significant of a change as the investigators assessed the technique and documented that plasma-free hemoglobin importantly did not rise and that measured osmolality was still slightly above the normal range.

Study type: Prospective randomized controlled study.

Hypothesis: The investigators hypothesize that pre cardiopulmonary bypass ultrafiltration (PBUF) can provide more physiologic prime values for glucose, sodium, potassium and lactate. Plasma-free hemoglobin will not increase with the technique. Osmolality will be maintained slightly above the normal range. PBUF will not negatively impact clinical outcome measures and may improve them.

Specific Aim 1 To determine if use of PBUF will result in more physiologic values for glucose, sodium, potassium and lactate during and immediately after cardiopulmonary bypass.

Specific Aim 2 To determine if PBUF can be achieved with no increase in plasma free hemoglobin while maintaining plasma osmolality within acceptable range during and immediately after cardiopulmonary bypass.

Specific Aim 3 To determine if use of PBUF will result in improved clinical outcomes after surgery on cardiopulmonary bypass.

Randomization: Prior to surgery, subjects will be randomized to one of the two study groups using a randomly permuted blocks design.

Statistical analysis: Analyses will be performed on an intention to treat basis. Comparisons of subject characteristics and outcomes will be made using the two-sample t test or Wilcoxon rank sum test for continuous variables, and Fisher's exact test for categorical variables. If imbalances in patient factors exist between the two groups, linear and logistic regression will be used to compare outcomes for the groups adjusting for these potential confounders.

Sample size calculation: Sample size is calculated for comparisons of subjects in the normal range of values for the PBUF and standard care groups. This will be done separately for glucose, sodium, potassium, and lactate; each comparison will be performed at the 0.0125 level of significance. If 70% of standard care subjects are in the normal range versus 90% of PBUF subjects, a total of 176 subjects (88 per group) would be required to achieve 80% power. With 350 eligible subjects that meet inclusion criteria based on 2017 numbers and 75% consent rate the investigators will be able to enroll 260 subjects in 1 year.

Given COVID-19 restrictions, the study is on hold.

Conditions: Congenital Heart Disease
Being tested: Use of prebypass ultrafiltration (PBUF)
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.

Use of prebypass ultrafiltration (PBUF)Other
In addition to standard of care for cardiopulmonary bypass, in the study arm prebypass ultrafiltration will be performed.

Study groups in NCT03576534
Study group	Role	What they receive
Control	No intervention	Standard of care
Study	Active comparator	PBUF used prior to Cardiopulmonary bypass Receives: Other: Use of prebypass ultrafiltration (PBUF)

What is being measured

The primary outcome is the main question the study is designed to answer.

Glucose in milligrams per deciliter (mg/dL). Normal range 61 to 199 mg/dL
Differences in glucose (mg/dl) at the following time points, and also differences in the percentage of values within the normal range for each time point, for PBUF versus standard care.
1. Final prime value (in the PBUF group after completion of PBUF and prior to cardio pulmonary bypass (CPB), in the control group prior to CPB)
2. First measured levels on bypass - typically 10 minutes post initiation of bypass
3. Last value on CPB
4. Last value in OR
5. First arrival to ICU
Measured: 12 hours
Sodium in milliequivalents per liter (mEq/L). Normal range 135 to 148 mEq/L
Differences in sodium (mEq/L) at the following time points, and also differences in the percentage of values within the normal range for each time point, for PBUF versus standard care.
1. Final prime value (in the PBUF group after completion of PBUF and prior to cardio pulmonary bypass (CPB), in the control group prior to CPB)
2. First measured levels on bypass - typically 10 minutes post initiation of bypass
3. Last value on CPB
4. Last value in OR
5. First arrival to ICU
Measured: 12 hours
Potassium in milliequivalents per liter (mEq/L). Normal range 3.2 to 4.5 mEg/L
Differences in potassium (mEq/L) at the following time points, and also differences in the percentage of values within the normal range for each time point, for PBUF versus standard care.
1. Final prime value (in the PBUF group after completion of PBUF and prior to cardio pulmonary bypass (CPB), in the control group prior to CPB)
2. First measured levels on bypass - typically 10 minutes post initiation of bypass
3. Last value on CPB
4. Last value in OR
5. First arrival to ICU
Measured: 12 hours
Lactate in milliequivalents per liter (mEq/L). Normal range 0.5 to 2.2 mEq/L
Differences in lactate (mEq/L) at the following time points, and also differences in the percentage of values within the normal range for each time point, for PBUF versus standard care.
1. Final prime value (in the PBUF group after completion of PBUF and prior to cardio pulmonary bypass (CPB), in the control group prior to CPB)
2. First measured levels on bypass - typically 10 minutes post initiation of bypass
3. Last value on CPB
4. Last value in OR
5. First arrival to ICU
Measured: 12 hours

Secondary outcomes (11)

Osmolality in milli osmoles per kilogram (mOsm/Kg). Normal Range 276- 295 mOsm/kg
Differences in osmolality in mOsm/Kg in final prime, first blood draw after CPB and on arrival to cardiac intensive care unit (CICU) for PBUF versus standard care.
Measured: 12 hours
Plasma free hemoglobin in milligrams per deciliter (mg/dL). Normal < 5 mg/dL.
Differences in plasma free hemoglobin in mg/dL in final prime, first blood draw after CPB and on arrival to cardiac intensive care unit (CICU) for PBUF versus standard care.
Measured: 12 hours
Inotrope use
Differences in vasoactive inotrope score between the PBUF and standard care groups at the following time points:
1. Between cessation of CPB and admission to CICU as measured by vasoactive inotrope score (VIS) ii. In CICU as measure by VIS/ 24 hours for first 72 hours
Measured: 72 hours
Body wall edema as measured daily weights in kilograms (Kg)
Differences in body wall edema as measure by daily weights in Kg between the PBUF and standard care groups.
Measured: Through study completion (until hospital discharge), an average of 15 days.
Body wall edema as measured daily weights in kilograms (Kg)
Differences in body wall edema as measure by daily weights in Kg between the PBUF and standard care groups.
Measured: Through study completion (until hospital discharge) , an average of 15 days.
Initial ventilation duration in days and hours
Differences in ventilation duration, Initial (days, hours) until first extubation between the PBUF and standard care groups.
Measured: Through study completion (until hospital discharge), an average of 15 days.
Reintubation as a proportion subjects needing reintubation in each group Reintubation
Difference in proportion of subjects requiring unplanned reintubation for respiratory failure between the PBUF and standard care groups.
Measured: Through study completion (until hospital discharge), an average of 15 days.
Total ventilation duration (days, hours)
Difference in total ventilation duration (includes all periods on the ventilator including period following unplanned reintubation for respiratory failure between the PBUF and standard care groups.
Measured: Through study completion (until hospital discharge), an average of 15 days.
Postoperative Cardiac intensive care unit (CICU) length of stay (LOS) in days,
Difference in postoperative CICU LOS in days between the PBUF and standard care groups.
Measured: Through study completion (until hospital discharge), an average of 15 days.
Postoperative hospital LOS
Difference in postoperative hospital LOS in days between the PBUF and standard care groups.
Measured: Through study completion (until hospital discharge), an average of 15 days.
Composite of major adverse events (Postoperative extra corporeal membrane oxygenation (ECMO), reoperation for bleeding, reoperation for low cardiac output state, circuit clotting events) and mortality. Yes or No
Difference in proportion subjects who have a composite event between the PBUF and standard care groups.
Measured: Through study completion (until hospital discharge), an average of 15 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Oct 201913 Sep 2021

First posted3 Jul 2018
Study start3 Oct 2019
Primary completion13 Sep 2021
Study completion13 Sep 2021

Why it stopped: Given SARS CoV2 pandemic, we had difficulty enrolling patients in the proposed time frame

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)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 Boston Children's HospitalThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized Control Trial
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03576534
Sponsor's protocol ID: P00028603
Acronym: PBUF
Status last verified: Feb 2022
First submitted: 29 May 2018
Last updated: 2 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Moore GL, Peck CC, Sohmer PR, Zuck TF. Some properties of blood stored in anticoagulant CPDA-1 solution. A brief summary. Transfusion. 1981 Mar-Apr;21(2):135-7. doi: 10.1046/j.1537-2995.1981.21281178147.x.
PubMed 7222197
de Vroege R, Wildevuur WR, Muradin JA, Graves D, van Oeveren W. Washing of stored red blood cells by an autotransfusion device before transfusion. Vox Sang. 2007 Feb;92(2):130-5. doi: 10.1111/j.1423-0410.2006.00852.x.
PubMed 17298575
Hall TL, Barnes A, Miller JR, Bethencourt DM, Nestor L. Neonatal mortality following transfusion of red cells with high plasma potassium levels. Transfusion. 1993 Jul;33(7):606-9. doi: 10.1046/j.1537-2995.1993.33793325059.x.
PubMed 8333025
Baz EM, Kanazi GE, Mahfouz RA, Obeid MY. An unusual case of hyperkalaemia-induced cardiac arrest in a paediatric patient during transfusion of a 'fresh' 6-day-old blood unit. Transfus Med. 2002 Dec;12(6):383-6. doi: 10.1046/j.1365-3148.2002.00402.x.
PubMed 12473156
O'Leary MF, Szklarski P, Klein TM, Young PP. Hemolysis of red blood cells after cell washing with different automated technologies: clinical implications in a neonatal cardiac surgery population. Transfusion. 2011 May;51(5):955-60. doi: 10.1111/j.1537-2995.2010.02935.x. Epub 2010 Nov 23.
PubMed 21091957
Masalunga C, Cruz M, Porter B, Roseff S, Chui B, Mainali E. Increased hemolysis from saline pre-washing RBCs or centrifugal pumps in neonatal ECMO. J Perinatol. 2007 Jun;27(6):380-4. doi: 10.1038/sj.jp.7211748. Epub 2007 Apr 19.
PubMed 17443201
Rao R, Georgieff MK. Iron in fetal and neonatal nutrition. Semin Fetal Neonatal Med. 2007 Feb;12(1):54-63. doi: 10.1016/j.siny.2006.10.007. Epub 2006 Dec 6.
PubMed 17157088
Mumby S, Chaturvedi RR, Brierley J, Lincoln C, Petros A, Redington AN, Gutteridge JM. Iron overload in paediatrics undergoing cardiopulmonary bypass. Biochim Biophys Acta. 2000 Mar 17;1500(3):342-8. doi: 10.1016/s0925-4439(00)00003-x.
PubMed 10699376
Jeffers A, Gladwin MT, Kim-Shapiro DB. Computation of plasma hemoglobin nitric oxide scavenging in hemolytic anemias. Free Radic Biol Med. 2006 Nov 15;41(10):1557-65. doi: 10.1016/j.freeradbiomed.2006.08.017. Epub 2006 Aug 25.
PubMed 17045924
Vercaemst L. Hemolysis in cardiac surgery patients undergoing cardiopulmonary bypass: a review in search of a treatment algorithm. J Extra Corpor Technol. 2008 Dec;40(4):257-67.
PubMed 19192755
Messent M, Sinclair DG, Quinlan GJ, Mumby SE, Gutteridge JM, Evans TW. Pulmonary vascular permeability after cardiopulmonary bypass and its relationship to oxidative stress. Crit Care Med. 1997 Mar;25(3):425-9. doi: 10.1097/00003246-199703000-00009.
PubMed 9118657
Hackbarth RM, Eding D, Gianoli Smith C, Koch A, Sanfilippo DJ, Bunchman TE. Zero balance ultrafiltration (Z-BUF) in blood-primed CRRT circuits achieves electrolyte and acid-base homeostasis prior to patient connection. Pediatr Nephrol. 2005 Sep;20(9):1328-33. doi: 10.1007/s00467-005-1970-1. Epub 2005 Jun 10.
PubMed 15947984
Delaney M, Axdorff-Dickey RL, Crockett GI, Falconer AL, Levario MJ, McMullan DM. Risk of extracorporeal life support circuit-related hyperkalemia is reduced by prebypass ultrafiltration. Pediatr Crit Care Med. 2013 Jul;14(6):e263-7. doi: 10.1097/PCC.0b013e31828a70c5.
PubMed 23823207
Nagashima M, Imai Y, Seo K, Terada M, Aoki M, Shinoka T, Koide M. Effect of hemofiltrated whole blood pump priming on hemodynamics and respiratory function after the arterial switch operation in neonates. Ann Thorac Surg. 2000 Dec;70(6):1901-6. doi: 10.1016/s0003-4975(00)02024-5.
PubMed 11156092
Grist G. Boiling the frog: the dangers of elevated sodium in blood primed pumps for infants. AmSECT Today.2012;Nov/Dec:5.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pre Bypass Ultrafiltration (PBUF) Improves Intraoperative Glucose, Sodium, Potassium and Lactate Levels in Children Requiring Cardiopulmonary Bypass
ClinicalTrials.gov ID: NCT03576534
Acronym / sponsor ID: PBUF / P00028603
Conditions: Congenital Heart Disease
Study type: Interventional
Recruitment status: TerminatedReason stopped: Given SARS CoV2 pandemic, we had difficulty enrolling patients in the proposed time frame
Enrolment: 13 participants (actual)
Lead sponsor: Boston Children's HospitalUniversity, hospital or other
Study start: 3 Oct 2019 (actual)
Primary completion: 13 Sep 2021 (actual)
Study completion: 13 Sep 2021 (actual)
First posted: 3 Jul 2018 (actual)
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.

Newborn babies and children with congenital heart defects who need heart surgery need to be placed on the heart-lung machine for heart surgery.

Given COVID -19 restrictions, the study is on hold.

Detailed description

Research question: Can PBUF provide more physiologic values for glucose, sodium, potassium and lactate throughout the cardiopulmonary bypass period without an increased incidence of adverse events?

Study type: Prospective randomized controlled study.

Specific Aim 1 To determine if use of PBUF will result in more physiologic values for glucose, sodium, potassium and lactate during and immediately after cardiopulmonary bypass.

Specific Aim 3 To determine if use of PBUF will result in improved clinical outcomes after surgery on cardiopulmonary bypass.

Randomization: Prior to surgery, subjects will be randomized to one of the two study groups using a randomly permuted blocks design.

Given COVID-19 restrictions, the study is on hold.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized Control Trial

Arm	Type	Receives
Control	No intervention	–Standard of care
Study	Active comparator	Other: Use of prebypass ultrafiltration (PBUF)PBUF used prior to Cardiopulmonary bypass

Who may qualify

Ages: 1 day to 1 year
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

All patients < 8 kilograms and < 1 year (to ensure that all patients receive steroids at initiation of CPB) undergoing an index cardiac operation for that hospitalization (using a single PBUF protocol)

Key exclusion criteria (3 listed)

Patients undergoing repeat cardiac surgery within the same admission
Patients undergoing transplants as their index surgery
Patients undergoing Ventricular assist device implantation as their index surgery

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
Use of prebypass ultrafiltration (PBUF)In addition to standard of care for cardiopulmonary bypass, in the study arm prebypass ultrafiltration will be performed.	Other	Study

Primary outcome

Glucose in milligrams per deciliter (mg/dL). Normal range 61 to 199 mg/dL
Time frame: 12 hours
Differences in glucose (mg/dl) at the following time points, and also differences in the percentage of values within the normal range for each time point, for PBUF versus standard care. 1. Final prime value (in the PBUF group after completion of PBUF and prior to cardio pulmonary bypass (CPB), in the control group prior to CPB) 2. First measured levels on bypass - typically 10 minutes post initiation of bypass 3. Last value on CPB 4. Last value in OR 5. First arrival to ICU
Sodium in milliequivalents per liter (mEq/L). Normal range 135 to 148 mEq/L
Time frame: 12 hours
Differences in sodium (mEq/L) at the following time points, and also differences in the percentage of values within the normal range for each time point, for PBUF versus standard care. 1. Final prime value (in the PBUF group after completion of PBUF and prior to cardio pulmonary bypass (CPB), in the control group prior to CPB) 2. First measured levels on bypass - typically 10 minutes post initiation of bypass 3. Last value on CPB 4. Last value in OR 5. First arrival to ICU
Potassium in milliequivalents per liter (mEq/L). Normal range 3.2 to 4.5 mEg/L
Time frame: 12 hours
Differences in potassium (mEq/L) at the following time points, and also differences in the percentage of values within the normal range for each time point, for PBUF versus standard care. 1. Final prime value (in the PBUF group after completion of PBUF and prior to cardio pulmonary bypass (CPB), in the control group prior to CPB) 2. First measured levels on bypass - typically 10 minutes post initiation of bypass 3. Last value on CPB 4. Last value in OR 5. First arrival to ICU
Lactate in milliequivalents per liter (mEq/L). Normal range 0.5 to 2.2 mEq/L
Time frame: 12 hours
Differences in lactate (mEq/L) at the following time points, and also differences in the percentage of values within the normal range for each time point, for PBUF versus standard care. 1. Final prime value (in the PBUF group after completion of PBUF and prior to cardio pulmonary bypass (CPB), in the control group prior to CPB) 2. First measured levels on bypass - typically 10 minutes post initiation of bypass 3. Last value on CPB 4. Last value in OR 5. First arrival to ICU

11 secondary outcomes

Osmolality in milli osmoles per kilogram (mOsm/Kg). Normal Range 276- 295 mOsm/kg
Time frame: 12 hours
Plasma free hemoglobin in milligrams per deciliter (mg/dL). Normal < 5 mg/dL.
Time frame: 12 hours
Inotrope use
Time frame: 72 hours
Body wall edema as measured daily weights in kilograms (Kg)
Time frame: Through study completion (until hospital discharge), an average of 15 days.
Body wall edema as measured daily weights in kilograms (Kg)
Time frame: Through study completion (until hospital discharge) , an average of 15 days.
Initial ventilation duration in days and hours
Time frame: Through study completion (until hospital discharge), an average of 15 days.
Reintubation as a proportion subjects needing reintubation in each group Reintubation
Time frame: Through study completion (until hospital discharge), an average of 15 days.
Total ventilation duration (days, hours)
Time frame: Through study completion (until hospital discharge), an average of 15 days.
Postoperative Cardiac intensive care unit (CICU) length of stay (LOS) in days,
Time frame: Through study completion (until hospital discharge), an average of 15 days.
Postoperative hospital LOS
Time frame: Through study completion (until hospital discharge), an average of 15 days.
Composite of major adverse events (Postoperative extra corporeal membrane oxygenation (ECMO), reoperation for bleeding, reoperation for low cardiac output state, circuit clotting events) and mortality. Yes or No
Time frame: Through study completion (until hospital discharge), an average of 15 days.

Results and safety

The study was stopped early (reason given: Given SARS CoV2 pandemic, we had difficulty enrolling patients in the proposed time frame). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
Background: PubMed 7222197Moore GL, Peck CC, Sohmer PR, Zuck TF. Some properties of blood stored in anticoagulant CPDA-1 solution. A brief summary. Transfusion. 1981 Mar-Apr;21(2):135-7. doi: 10.1046/j.1537-2995.1981.21281178147.x.
Background: PubMed 17298575de Vroege R, Wildevuur WR, Muradin JA, Graves D, van Oeveren W. Washing of stored red blood cells by an autotransfusion device before transfusion. Vox Sang. 2007 Feb;92(2):130-5. doi: 10.1111/j.1423-0410.2006.00852.x.
Background: PubMed 8333025Hall TL, Barnes A, Miller JR, Bethencourt DM, Nestor L. Neonatal mortality following transfusion of red cells with high plasma potassium levels. Transfusion. 1993 Jul;33(7):606-9. doi: 10.1046/j.1537-2995.1993.33793325059.x.
Background: PubMed 12473156Baz EM, Kanazi GE, Mahfouz RA, Obeid MY. An unusual case of hyperkalaemia-induced cardiac arrest in a paediatric patient during transfusion of a 'fresh' 6-day-old blood unit. Transfus Med. 2002 Dec;12(6):383-6. doi: 10.1046/j.1365-3148.2002.00402.x.
Background: PubMed 21091957O'Leary MF, Szklarski P, Klein TM, Young PP. Hemolysis of red blood cells after cell washing with different automated technologies: clinical implications in a neonatal cardiac surgery population. Transfusion. 2011 May;51(5):955-60. doi: 10.1111/j.1537-2995.2010.02935.x. Epub 2010 Nov 23.
Background: PubMed 17443201Masalunga C, Cruz M, Porter B, Roseff S, Chui B, Mainali E. Increased hemolysis from saline pre-washing RBCs or centrifugal pumps in neonatal ECMO. J Perinatol. 2007 Jun;27(6):380-4. doi: 10.1038/sj.jp.7211748. Epub 2007 Apr 19.
Background: PubMed 17157088Rao R, Georgieff MK. Iron in fetal and neonatal nutrition. Semin Fetal Neonatal Med. 2007 Feb;12(1):54-63. doi: 10.1016/j.siny.2006.10.007. Epub 2006 Dec 6.
Background: PubMed 10699376Mumby S, Chaturvedi RR, Brierley J, Lincoln C, Petros A, Redington AN, Gutteridge JM. Iron overload in paediatrics undergoing cardiopulmonary bypass. Biochim Biophys Acta. 2000 Mar 17;1500(3):342-8. doi: 10.1016/s0925-4439(00)00003-x.
Background: PubMed 17045924Jeffers A, Gladwin MT, Kim-Shapiro DB. Computation of plasma hemoglobin nitric oxide scavenging in hemolytic anemias. Free Radic Biol Med. 2006 Nov 15;41(10):1557-65. doi: 10.1016/j.freeradbiomed.2006.08.017. Epub 2006 Aug 25.
Background: PubMed 19192755Vercaemst L. Hemolysis in cardiac surgery patients undergoing cardiopulmonary bypass: a review in search of a treatment algorithm. J Extra Corpor Technol. 2008 Dec;40(4):257-67.
Background: PubMed 9118657Messent M, Sinclair DG, Quinlan GJ, Mumby SE, Gutteridge JM, Evans TW. Pulmonary vascular permeability after cardiopulmonary bypass and its relationship to oxidative stress. Crit Care Med. 1997 Mar;25(3):425-9. doi: 10.1097/00003246-199703000-00009.
Background: PubMed 15947984Hackbarth RM, Eding D, Gianoli Smith C, Koch A, Sanfilippo DJ, Bunchman TE. Zero balance ultrafiltration (Z-BUF) in blood-primed CRRT circuits achieves electrolyte and acid-base homeostasis prior to patient connection. Pediatr Nephrol. 2005 Sep;20(9):1328-33. doi: 10.1007/s00467-005-1970-1. Epub 2005 Jun 10.
Individual participant dataSharing planned: No

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Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation

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.

Meena Nathan, MD, MPH study chair

Boston Children's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Use of prebypass ultrafiltration (PBUF) in people with Congenital Heart Disease, run by Boston Children's Hospital 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: stopped early, as of the sponsor's last update on 2 Mar 2022. 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 stopped early (reason given: Given SARS CoV2 pandemic, we had difficulty enrolling patients in the proposed time frame). 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?

Glucose in milligrams per deciliter (mg/dL). Normal range 61 to 199 mg/dL (time frame: 12 hours). The study lists 4 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 NCT03576534, which also lists 16 linked publications.

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 2 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.