Ventricular Septal DefectNCT07393243
Bypass Clear Priming VSD Cardiopulmonary Bypass Circuit Reduce Bypass Associated Inflammation?
A study testing Clear priming of the bypass pump in people with Ventricular Septal Defect, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
The purpose of this trial is to study if priming the pump used during cardiac surgery with non-blood fluids instead of donated blood products reduces the inflammation that occurs after heart surgery. Read more about this study
- Who is it for?
- Ages 1 month to 18 months
- Conditions the study is for
- Ventricular Septal Defect
- What is being tested?
- Clear priming of the bypass pump
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 month to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Weight between 5-10kg
- Age 1-18 months
- Requiring cardiopulmonary bypass as part of clinically indicated surgery
- Surgery performed by Dr. Bohuta or Dr. Greene
Who cannot join
- Hemoglobin/hematocrit too low for clear CPB prime (post-dilution Hct <24%)
- Pre-operative ECMO support
- Active infection
- Not clinically appropriate for clear prime (instability, arrhythmias, desaturation, etc.)
- Genetic syndrome
- Pork allergy or family requests pork avoidance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98115
About this study
Official title: Does Clear Priming of the Cardiopulmonary Bypass Circuit Reduce Bypass Associated Inflammation in Ventricular Septal Defect Patients?
The purpose of this trial is to study if priming the pump used during cardiac surgery with non-blood fluids instead of donated blood products reduces the inflammation that occurs after heart surgery. The study will focused on pediatric participants who require open heart surgery to repair certain types holes in the heart.
Typically for pediatric patients, the cardiopulmonary bypass pump is "primed" (filled) with donated blood products. This project is going to test if the exposure to these blood products causes inflammation. Patients experience significant inflammation (swelling) after undergoing cardiopulmonary bypass. This inflammation can interfere and slow down the patient's recovery from cardiac surgery. With this project, the investigator are studying if filling the bypass pump with non-blood products reduces the bypass-associated inflammation.
Read more
The investigators are also studying if using non-blood fluids to fill the bypass pump reduces bypass associated side effects.
The investigators are also trying to understand how the inflammation starts. The investigators also want to study genetic material called DNA that is collected from a person's blood. Instructions for the body are contained in parts of DNA called genes. Genes determine things like hair and eye color. The investigator hope by studying genes the investigator can learn more about the inflammation that occurs after heart surgery, but the investigators might use participant's genetic information to study other diseases or conditions other the inflammation that occurs after heart surgery.
The investigators will be studying the recovery of 60 participants between 1 month to 18 months of age who require open heart surgery to repair ventricular septal defects (VSDs), a congenital heart defect where there a hole between the lower chambers of the heart.
Participants will:
Allow for information about how the participants recover from surgery to be collected.
Allow blood samples during and after surgery to be collected to understand how the markers of inflammation change between the two groups (blood versus non-blood priming).
Read the detailed description
Cardiopulmonary bypass (CPB) is required for surgical correction/palliation of congenital heart defects. Exposure to CPB results in a robust activation of inflammatory responses. It is now well established that exposure to the CPB circuit is associated with an overwhelming, detrimental systemic inflammatory response. The factors associated with this response may be related to the circuit and exposure to the circuit surface, or may be associated with the body's response to surgical trauma, changes in temperature, etc. Multiple pathways have been shown to be mediating this response, including complement activation, leukocyte activation, endotoxin release, release of oxygen-free radicals, nitric oxide, cytokines, platelet-activation factor, arachidonic acid metabolites and endothelins. Activation of these inflammatory pathways has been implicated in the development of some of the major postoperative complications, such as bleeding tendencies, respiratory insufficiency, renal dysfunction, abnormalities in liver function, and, most seriously, multi-organ failure. Multiple pharmacological therapies have been investigated, with a single aim, to modulate this systemic inflammation. The most widely investigated ones have been corticosteroid administration, use of heparin-coated circuits, leukocyte depletion and ultrafiltration. Despite these efforts, the activation of inflammatory pathways in response to CPB remains a significant clinical problem especially in neonates undergoing CPB.
Over the last several years, several centers including Seattle Children's have been pursuing efforts to restrict the administration of blood products during CPB. In some of the recent publications on the topic, the justifications for moving towards "bloodless CPB" include reducing potential infection risks, consideration that blood products are valuable limited resource, and the concerns of certain religious communities. A limitation of these studies is that they do not examine a patient's clinical course or markers of inflammation in depth. CPB patients experience significant post-CPB inflammation - including increased cytokine levels, inflammatory cell infiltration, vascular leak, and multi-organ dysfunction. In children recovering from complicated cardiac surgeries, increased cytokine levels are associated with high mortality and extended intensive care stays. Typically, a blood-containing prime has been used as a method to preserve high hematocrit levels and maintain oxygen delivery. There are several mechanisms by which exposure to blood products can activate inflammation-which include allergic reactions, cytokines in the blood products, or release of proinflammatory proteins from red blood cells. These mechanisms serve as the basis for the hypothesis that "clear prime" CPB patients will have reduced inflammation as compared to standard of care CPB patients.
Since 5/2021, 174 CPB patients have been operated on at Seattle Children's Hospital (SCH) using restrictive blood management. In 90 of these patients, "bloodless" surgery was attempted. These patients received CPB priming with crystalloid fluids only and without any addition of blood products. These crystalloid fluids are same ones used in current standard of care treatment for pediatric cardiac surgery cases. All other aspects of the patients' treatment were the same including the same bypass machines and tubing. 47 of these patients did not receive blood products during the surgery. 35 patients did not receive any blood products during the hospitalization. There were no statistical differences between the median ventilation time and Intensive Care Unit (ICU) length of stay between the patients operated on with such restrictive blood management as compared to patient controls from our center in which blood products were added to CPB prime.
Dr. Bohuta's recent observational study of 99 SCH neonatal cardiac cases using historical controls identified no statistical difference in postoperative seizures, bleeding events, and lactate levels during CPB between patients who received clear prime versus those who received a blood prime. In this same study, both length of stay and postoperative mechanical ventilation time was shorter in the clear prime group. Hematocrit was consistently lower post-operatively for patients in the crystalloid only group, otherwise, there were no unintended consequences/ adverse events identified in the crystalloid only cohort.
- Conditions
- Ventricular Septal Defect
- Being tested
- Clear priming of the bypass pump
- Keywords
- cardiac surgery, cardiopulmonary bypass, inflammation, blood product
- Medical subject headings
- Heart Septal Defects, Ventricular, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear priming of the bypass pumpProcedure or surgery
The intervention is priming the pump with non-blood products.
| Study group | Role | What they receive |
|---|---|---|
| Blood prime | No intervention | The research participants in this arm will undergo their clinically indicated cardiac surgery. The control group will have the bypass pumped primed with mixture of crystalloid solution and blood, which is currently standard of care. |
| Clear prime | Experimental | The research participants in this arm will undergo their clinically indicated cardiac surgery. The experimental group will have the bypass pump primed with mixture of crystalloid solution, non-blood fluids. Receives: Procedure: Clear priming of the bypass pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in RNA expression of the inflammatory marker TNF-α fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB
Plasma from blood samples collected during four timepoints spanning from pre-CPB to 24 hours post-CPB will be analyzed via RNA-Seq to assess changes in TNF-α fold levels. RNA-Seq measures change in gene expression relative to baseline, with higher relative gene expression indicated higher inflammation.
Measured: Up to 24 hours post surgery
Changes in protein expression of the inflammatory marker TNF-α fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB
Plasma from blood samples collected during four timepoints spanning from pre-CPB to 24 hours post-CPB will be analyzed ELISA to assess changes in TNF-α fold levels. ELISA measures concentration in picograms per milliliter, with higher scores indicating more inflammation.
Measured: Up to 24 hours post surgery
Changes in RNA expression of the inflammatory marker IL8 fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB
Plasma from blood samples collected during four timepoints spanning from pre-CPB to 24 hours post-CPB will be analyzed via RNA-Seq to assess changes in IL8 fold levels. RNA-Seq measures change in gene expression relative to baseline, with higher relative gene expression indicated higher inflammation.
Measured: Up to 24 hours post surgery
Changes in protein expression of the inflammatory marker IL8 fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB
Plasma from blood samples collected during four timepoints spanning from pre-CPB to 24 hours post-CPB will be analyzed via ELISA to assess changes in IL8 fold levels. ELISA measures concentration in picograms per milliliter, with higher scores indicating more inflammation.
Measured: Up to 24 hours post surgery
Secondary outcomes (4)
Time to extubation
Clinical data will be collected to measure the number of hours and minutes post-surgery until participants are extubated.
Measured: From intubation until extubation (up to 24 hours post-surgery)
Peak lactic acid levels over the first 24 hours post-surgery
Clinical laboratory data will be reviewed to identify the highest lactic acid (Normal: ≤2 mmol/L) value recorded within the first 24 hours after surgery. Lactic acid levels (measured in mmol/L) indicate how well the body is delivering oxygen to tissues after surgery.
Measured: Up to 24 hours post-surgery
Vasoactive-inotropic score over the first 24 hours post-surgery
Clinical data will be collected to determine how much ionotropic support is needed during the first 24 hours after surgery. The vasoactive-inotropic score typically range from 0 to 15, with higher scores indicating a greater need for inotropic support and worse outcomes, and values above 15 are considered atypical.
Measured: Up to 24 hours post-surgery
Length of hospital stay post-surgery
Clinical information will be collected from participants' medical charts to measure the length of hospital stay (in days) after surgery.
Measured: From the date of surgery until the date of hospital discharge, assessed up to 90 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start25 Feb 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Ventricular Septal DefectStudies of the same condition, open and under way.
- More trials run by Seattle 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vishal Nigam, Seattle Children's Hospital
- Investigators
- Vishal Nigam, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393243
- Sponsor's protocol ID
- STUDY00003941
- Status last verified
- Dec 2025
- First submitted
- 12 Apr 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD) that underlie results in publication will be shared.
Publications
Van Gassen S, Callebaut B, Van Helden MJ, Lambrecht BN, Demeester P, Dhaene T, Saeys Y. FlowSOM: Using self-organizing maps for visualization and interpretation of cytometry data. Cytometry A. 2015 Jul;87(7):636-45. doi: 10.1002/cyto.a.22625. Epub 2015 Jan 8.
PubMed 25573116Nellis ME, Karam O, Valentine SL, Bateman ST, Remy KE, Lacroix J, Cholette JM, Bembea MM, Russell RT, Steiner ME, Goobie SM, Tucci M, Stricker PA, Stanworth SJ, Delaney M, Lieberman L, Muszynski JA, Bauer DF, Steffen K, Nishijima D, Ibla J, Emani S, Vogel AM, Haas T, Goel R, Crighton G, Delgado D, Demetres M, Parker RI; Pediatric Critical Care Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB), in collaboration with the Pediatric Critical Care Blood Research Network (BloodNet), and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Executive Summary of Recommendations and Expert Consensus for Plasma and Platelet Transfusion Practice in Critically Ill Children: From the Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB). Pediatr Crit Care Med. 2022 Jan 1;23(1):34-51. doi: 10.1097/PCC.0000000000002851.
PubMed 34989711Burnside JL, Ratliff TM, Kelly MN, Naguib AN, Galantowicz M, Hodge A. Bloodless Arterial Switch Operation in a 2.7-kg Jehovah's Witness Patient. J Extra Corpor Technol. 2020 Jun;52(2):142-145. doi: 10.1182/ject-2000003.
PubMed 32669741Wloch A, Boettcher W, Sinzobahamvya N, Cho MY, Redlin M, Dahnert I, Photiadis J. Bloodless priming of the cardiopulmonary bypass circuit: determinants of successful transfusion-free operation in neonates and infants with a maximum body weight of 7 kg. Cardiol Young. 2018 Oct;28(10):1141-1147. doi: 10.1017/S1047951118001154. Epub 2018 Jul 23.
PubMed 30033907Faraoni D, Meier J, New HV, Van der Linden PJ, Hunt BJ. Patient Blood Management for Neonates and Children Undergoing Cardiac Surgery: 2019 NATA Guidelines. J Cardiothorac Vasc Anesth. 2019 Dec;33(12):3249-3263. doi: 10.1053/j.jvca.2019.03.036. Epub 2019 Mar 20.
PubMed 31076306Wypij D, Jonas RA, Bellinger DC, Del Nido PJ, Mayer JE Jr, Bacha EA, Forbess JM, Pigula F, Laussen PC, Newburger JW. The effect of hematocrit during hypothermic cardiopulmonary bypass in infant heart surgery: results from the combined Boston hematocrit trials. J Thorac Cardiovasc Surg. 2008 Feb;135(2):355-60. doi: 10.1016/j.jtcvs.2007.03.067.
PubMed 18242268Tu LN, Hsieh L, Kajimoto M, Charette K, Kibiryeva N, Forero A, Hampson S, Marshall JA, O'Brien J, Scatena M, Portman MA, Savan R, Benner C, Aliseda A, Nuri M, Bittel D, Pastuszko P, Nigam V. Shear stress associated with cardiopulmonary bypass induces expression of inflammatory cytokines and necroptosis in monocytes. JCI Insight. 2021 Jan 11;6(1):e141341. doi: 10.1172/jci.insight.141341.
PubMed 33232305Lam LKM, Murphy S, Kokkinaki D, Venosa A, Sherrill-Mix S, Casu C, Rivella S, Weiner A, Park J, Shin S, Vaughan AE, Hahn BH, Odom John AR, Meyer NJ, Hunter CA, Worthen GS, Mangalmurti NS. DNA binding to TLR9 expressed by red blood cells promotes innate immune activation and anemia. Sci Transl Med. 2021 Oct 20;13(616):eabj1008. doi: 10.1126/scitranslmed.abj1008. Epub 2021 Oct 20.
PubMed 34669439Bohuta L, Charette K, Chan T, Joffe D, Koth A, Greene CL, Mauchley D, McMullan DM. Encouraging results of blood conservation in neonatal open-heart surgery. J Thorac Cardiovasc Surg. 2024 Mar;167(3):1154-1163. doi: 10.1016/j.jtcvs.2023.07.032. Epub 2023 Jul 29.
PubMed 37517580Bozza MT, Jeney V. Pro-inflammatory Actions of Heme and Other Hemoglobin-Derived DAMPs. Front Immunol. 2020 Jun 30;11:1323. doi: 10.3389/fimmu.2020.01323. eCollection 2020.
PubMed 32695110Appachi E, Mossad E, Mee RB, Bokesch P. Perioperative serum interleukins in neonates with hypoplastic left-heart syndrome and transposition of the great arteries. J Cardiothorac Vasc Anesth. 2007 Apr;21(2):184-90. doi: 10.1053/j.jvca.2006.02.027. Epub 2006 May 30.
PubMed 17418729Kato H, Chasovskyi K, Gandhi SK. Are Blood Products Routinely Required in Pediatric Heart Surgery? Pediatr Cardiol. 2020 Jun;41(5):932-938. doi: 10.1007/s00246-020-02338-7. Epub 2020 Mar 13.
PubMed 32170329Boettcher W, Sinzobahamvya N, Miera O, Redlin M, Dehmel F, Cho MY, Murin P, Berger F, Photiadis J. Routine Application of Bloodless Priming in Neonatal Cardiopulmonary Bypass: A 3-Year Experience. Pediatr Cardiol. 2017 Apr;38(4):807-812. doi: 10.1007/s00246-017-1585-x. Epub 2017 Feb 14.
PubMed 28197644Naguib AN, Winch PD, Tobias JD, Simsic J, Hersey D, Nicol K, Preston T, Gomez D, McConnell P, Galantowicz M. A single-center strategy to minimize blood transfusion in neonates and children undergoing cardiac surgery. Paediatr Anaesth. 2015 May;25(5):477-86. doi: 10.1111/pan.12604. Epub 2015 Jan 12.
PubMed 25581204Klein HG. Immunomodulatory aspects of transfusion: a once and future risk? Anesthesiology. 1999 Sep;91(3):861-5. doi: 10.1097/00000542-199909000-00040. No abstract available.
PubMed 10485799
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Clear Priming of the Cardiopulmonary Bypass Circuit Reduce Bypass Associated Inflammation in Ventricular Septal Defect Patients?
- ClinicalTrials.gov ID
- NCT07393243
- Acronym / sponsor ID
- STUDY00003941
- Conditions
- Ventricular Septal Defect
- Keywords
- cardiac surgery, cardiopulmonary bypass, inflammation, blood product
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 25 Feb 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 6 Feb 2026 (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.
The purpose of this trial is to study if priming the pump used during cardiac surgery with non-blood fluids instead of donated blood products reduces the inflammation that occurs after heart surgery. The study will focused on pediatric participants who require open heart surgery to repair certain types holes in the heart.
Typically for pediatric patients, the cardiopulmonary bypass pump is "primed" (filled) with donated blood products. This project is going to test if the exposure to these blood products causes inflammation. Patients experience significant inflammation (swelling) after undergoing cardiopulmonary bypass. This inflammation can interfere and slow down the patient's recovery from cardiac surgery. With this project, the investigator are studying if filling the bypass pump with non-blood products reduces the bypass-associated inflammation.
The investigators are also studying if using non-blood fluids to fill the bypass pump reduces bypass associated side effects.
The investigators are also trying to understand how the inflammation starts. The investigators also want to study genetic material called DNA that is collected from a person's blood. Instructions for the body are contained in parts of DNA called genes. Genes determine things like hair and eye color. The investigator hope by studying genes the investigator can learn more about the inflammation that occurs after heart surgery, but the investigators might use participant's genetic information to study other diseases or conditions other the inflammation that occurs after heart surgery.
The investigators will be studying the recovery of 60 participants between 1 month to 18 months of age who require open heart surgery to repair ventricular septal defects (VSDs), a congenital heart defect where there a hole between the lower chambers of the heart.
Participants will:
Allow for information about how the participants recover from surgery to be collected.
Allow blood samples during and after surgery to be collected to understand how the markers of inflammation change between the two groups (blood versus non-blood priming).
Detailed description
Cardiopulmonary bypass (CPB) is required for surgical correction/palliation of congenital heart defects. Exposure to CPB results in a robust activation of inflammatory responses. It is now well established that exposure to the CPB circuit is associated with an overwhelming, detrimental systemic inflammatory response. The factors associated with this response may be related to the circuit and exposure to the circuit surface, or may be associated with the body's response to surgical trauma, changes in temperature, etc. Multiple pathways have been shown to be mediating this response, including complement activation, leukocyte activation, endotoxin release, release of oxygen-free radicals, nitric oxide, cytokines, platelet-activation factor, arachidonic acid metabolites and endothelins. Activation of these inflammatory pathways has been implicated in the development of some of the major postoperative complications, such as bleeding tendencies, respiratory insufficiency, renal dysfunction, abnormalities in liver function, and, most seriously, multi-organ failure. Multiple pharmacological therapies have been investigated, with a single aim, to modulate this systemic inflammation. The most widely investigated ones have been corticosteroid administration, use of heparin-coated circuits, leukocyte depletion and ultrafiltration. Despite these efforts, the activation of inflammatory pathways in response to CPB remains a significant clinical problem especially in neonates undergoing CPB.
Over the last several years, several centers including Seattle Children's have been pursuing efforts to restrict the administration of blood products during CPB. In some of the recent publications on the topic, the justifications for moving towards "bloodless CPB" include reducing potential infection risks, consideration that blood products are valuable limited resource, and the concerns of certain religious communities. A limitation of these studies is that they do not examine a patient's clinical course or markers of inflammation in depth. CPB patients experience significant post-CPB inflammation - including increased cytokine levels, inflammatory cell infiltration, vascular leak, and multi-organ dysfunction. In children recovering from complicated cardiac surgeries, increased cytokine levels are associated with high mortality and extended intensive care stays. Typically, a blood-containing prime has been used as a method to preserve high hematocrit levels and maintain oxygen delivery. There are several mechanisms by which exposure to blood products can activate inflammation-which include allergic reactions, cytokines in the blood products, or release of proinflammatory proteins from red blood cells. These mechanisms serve as the basis for the hypothesis that "clear prime" CPB patients will have reduced inflammation as compared to standard of care CPB patients.
Since 5/2021, 174 CPB patients have been operated on at Seattle Children's Hospital (SCH) using restrictive blood management. In 90 of these patients, "bloodless" surgery was attempted. These patients received CPB priming with crystalloid fluids only and without any addition of blood products. These crystalloid fluids are same ones used in current standard of care treatment for pediatric cardiac surgery cases. All other aspects of the patients' treatment were the same including the same bypass machines and tubing. 47 of these patients did not receive blood products during the surgery. 35 patients did not receive any blood products during the hospitalization. There were no statistical differences between the median ventilation time and Intensive Care Unit (ICU) length of stay between the patients operated on with such restrictive blood management as compared to patient controls from our center in which blood products were added to CPB prime.
Dr. Bohuta's recent observational study of 99 SCH neonatal cardiac cases using historical controls identified no statistical difference in postoperative seizures, bleeding events, and lactate levels during CPB between patients who received clear prime versus those who received a blood prime. In this same study, both length of stay and postoperative mechanical ventilation time was shorter in the clear prime group. Hematocrit was consistently lower post-operatively for patients in the crystalloid only group, otherwise, there were no unintended consequences/ adverse events identified in the crystalloid only cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood prime | No intervention | –The research participants in this arm will undergo their clinically indicated cardiac surgery. The control group will have the bypass pumped primed with mixture of crystalloid solution and blood, which is currently standard of care. |
| Clear prime | Experimental | Procedure: Clear priming of the bypass pumpThe research participants in this arm will undergo their clinically indicated cardiac surgery. The experimental group will have the bypass pump primed with mixture of crystalloid solution, non-blood fluids. |
Who may qualify
- Ages
- 1 month to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Weight between 5-10kg
- Age 1-18 months
- Requiring cardiopulmonary bypass as part of clinically indicated surgery
- Surgery performed by Dr. Bohuta or Dr. Greene
Key exclusion criteria (6 listed)
- Hemoglobin/hematocrit too low for clear CPB prime (post-dilution Hct <24%)
- Pre-operative ECMO support
- Active infection
- Not clinically appropriate for clear prime (instability, arrhythmias, desaturation, etc.)
- Genetic syndrome
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 |
|---|---|---|
| Clear priming of the bypass pumpThe intervention is priming the pump with non-blood products. | Procedure or surgery | Clear prime |
Primary outcome
Changes in RNA expression of the inflammatory marker TNF-α fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB
Time frame: Up to 24 hours post surgery
Plasma from blood samples collected during four timepoints spanning from pre-CPB to 24 hours post-CPB will be analyzed via RNA-Seq to assess changes in TNF-α fold levels. RNA-Seq measures change in gene expression relative to baseline, with higher relative gene expression indicated higher inflammation.
Changes in protein expression of the inflammatory marker TNF-α fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB
Time frame: Up to 24 hours post surgery
Plasma from blood samples collected during four timepoints spanning from pre-CPB to 24 hours post-CPB will be analyzed ELISA to assess changes in TNF-α fold levels. ELISA measures concentration in picograms per milliliter, with higher scores indicating more inflammation.
Changes in RNA expression of the inflammatory marker IL8 fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB
Time frame: Up to 24 hours post surgery
Plasma from blood samples collected during four timepoints spanning from pre-CPB to 24 hours post-CPB will be analyzed via RNA-Seq to assess changes in IL8 fold levels. RNA-Seq measures change in gene expression relative to baseline, with higher relative gene expression indicated higher inflammation.
Changes in protein expression of the inflammatory marker IL8 fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB
Time frame: Up to 24 hours post surgery
Plasma from blood samples collected during four timepoints spanning from pre-CPB to 24 hours post-CPB will be analyzed via ELISA to assess changes in IL8 fold levels. ELISA measures concentration in picograms per milliliter, with higher scores indicating more inflammation.
4 secondary outcomes
Time to extubation
Time frame: From intubation until extubation (up to 24 hours post-surgery)
Peak lactic acid levels over the first 24 hours post-surgery
Time frame: Up to 24 hours post-surgery
Vasoactive-inotropic score over the first 24 hours post-surgery
Time frame: Up to 24 hours post-surgery
Length of hospital stay post-surgery
Time frame: From the date of surgery until the date of hospital discharge, assessed up to 90 days post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Background: PubMed 25573116Van Gassen S, Callebaut B, Van Helden MJ, Lambrecht BN, Demeester P, Dhaene T, Saeys Y. FlowSOM: Using self-organizing maps for visualization and interpretation of cytometry data. Cytometry A. 2015 Jul;87(7):636-45. doi: 10.1002/cyto.a.22625. Epub 2015 Jan 8.
- Background: PubMed 34989711Nellis ME, Karam O, Valentine SL, Bateman ST, Remy KE, Lacroix J, Cholette JM, Bembea MM, Russell RT, Steiner ME, Goobie SM, Tucci M, Stricker PA, Stanworth SJ, Delaney M, Lieberman L, Muszynski JA, Bauer DF, Steffen K, Nishijima D, Ibla J, Emani S, Vogel AM, Haas T, Goel R, Crighton G, Delgado D, Demetres M, Parker RI; Pediatric Critical Care Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB), in collaboration with the Pediatric Critical Care Blood Research Network (BloodNet), and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Executive Summary of Recommendations and Expert Consensus for Plasma and Platelet Transfusion Practice in Critically Ill Children: From the Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB). Pediatr Crit Care Med. 2022 Jan 1;23(1):34-51. doi: 10.1097/PCC.0000000000002851.
- Background: PubMed 32669741Burnside JL, Ratliff TM, Kelly MN, Naguib AN, Galantowicz M, Hodge A. Bloodless Arterial Switch Operation in a 2.7-kg Jehovah's Witness Patient. J Extra Corpor Technol. 2020 Jun;52(2):142-145. doi: 10.1182/ject-2000003.
- Background: PubMed 30033907Wloch A, Boettcher W, Sinzobahamvya N, Cho MY, Redlin M, Dahnert I, Photiadis J. Bloodless priming of the cardiopulmonary bypass circuit: determinants of successful transfusion-free operation in neonates and infants with a maximum body weight of 7 kg. Cardiol Young. 2018 Oct;28(10):1141-1147. doi: 10.1017/S1047951118001154. Epub 2018 Jul 23.
- Background: PubMed 31076306Faraoni D, Meier J, New HV, Van der Linden PJ, Hunt BJ. Patient Blood Management for Neonates and Children Undergoing Cardiac Surgery: 2019 NATA Guidelines. J Cardiothorac Vasc Anesth. 2019 Dec;33(12):3249-3263. doi: 10.1053/j.jvca.2019.03.036. Epub 2019 Mar 20.
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- Individual participant dataSharing planned: Yes. Deidentified individual participant data (IPD) that underlie results in publication will be shared.
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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.
Vishal Nigam, MD principal investigator
Seattle 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 Clear priming of the bypass pump in people with Ventricular Septal Defect, run by Seattle 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie A Lammers, BSN (2069875916, stephanie.lammers@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in RNA expression of the inflammatory marker TNF-α fold pre-cardiopulmonary bypass (CPB) to 24 hours post-CPB (time frame: Up to 24 hours post surgery). 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 NCT07393243, which also lists 17 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 6 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.