Congenital Heart DiseaseLEATNCT07771491
Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT)
A study testing Hemoadsorption (Jafron HA-60/HA380) in people with Congenital Heart Disease and Open Heart Surgery, run by Norfaniza Zabidi.
Trial summary
The Localized Evidence of Cytokine Adsorption Therapy (LEAT) study is a prospective, randomized controlled trial conducted at the Institut Jantung Negara in Malaysia. It evaluates the efficacy and safety of using Jafron HA-60 and HA380 hemoadsorption cartridges to reduce systemic inflammation in pediatric patients… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Congenital Heart Disease, Open Heart Surgery, Cardiopulmonary Bypass
- What is being tested?
- Hemoadsorption (Jafron HA-60/HA380)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Oct 2028
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (<18 years old at study inclusion)
- Undergoing a cardiac surgery with CPB of expected duration > 180min
- Prophylactic application of HA during CPB for suspected SIRS.
Who cannot join
- Non-ability to gather informed consent from parents or legal representative. Enrolled in conflicting research study
- Off-pump procedure
- Non-steroidal anti-inflammatory treatment in the previous 7 days Pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The Localized Evidence of Cytokine Adsorption Therapy (LEAT) study is a prospective, randomized controlled trial conducted at the Institut Jantung Negara in Malaysia. It evaluates the efficacy and safety of using Jafron HA-60 and HA380 hemoadsorption cartridges to reduce systemic inflammation in pediatric patients undergoing major heart surgery.
Objective This study aims to compare the post-operative inflammatory response in children undergoing cardiac procedures treated with or without a cytokine.
Read more
Study Population All children < 18 years of age at the time of enrollment who are scheduled to undergo cardiac surgery involving cardiopulmonary bypass (CPB) with an expected duration of >180 minutes.
Methodology This single-center study will randomly assign patients before surgery into 2 groups: 1 group will receive hemoadsorption treatment plus with standard-of-care (intervention group), while the other group will receive standard-of-care (control group) only.
Primary Endpoint:
To evaluate changes in IL-6 plasma concentrations over the first 24 hours following the procedure. Analysis will be performed using a linear mixed-effects model (LMM) to capture both between-subject and within-subject variability across repeated time points. This method allows assessment of the overall trajectory of IL-6 and provides a clearer understanding of its temporal pattern throughout the 24-hour post-procedure period.
Secondary Endpoints:
- Changes cytokines (IL-8, IL-10, IL-1β, and TNF-α) plasma levels over 24 hours
- PELOD-2 score on ICU admission, at 48 hours post ICU admission
- ICU and hospital length of stay
- ICU, hospital, and 28 days mortality
- Mechanical - ventilation (MV) free days at day
- Renal replacement therapy (RRT) free days at day 28
- Vasopressors free days at day 28
- Acute kidney injury
- Bleeding complications
- Post operative liver injury
Data Collection:
Blood samples will be taken at five timepoints: before surgery, at ICU admission, and at 6, 24, and 48 hours post-procedure .
Duration: The study is expected to last 24 months.
- Conditions
- Congenital Heart Disease, Open Heart Surgery, Cardiopulmonary Bypass, Endocarditis Acute and Subacute, Cyanotic Heart Disease
- Being tested
- Hemoadsorption (Jafron HA-60/HA380)
- 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.
Hemoadsorption (Jafron HA-60/HA380)Device
Participants will receive hemoadsorption therapy using a Jafron HA-60 or HA380 cartridge in addition standard of care integrated into the cardiopulmonary bypass (CPB) circuit during surgery. The specific cartridge is chosen based on the patient's weight. The device works to filter out inflammatory proteins (cytokines) from the blood while the patient is on the heart-lung machine. This treatment starts at the beginning of the bypass and ends when the bypass is completed.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants undergoing cardiac surgery with cardiopulmonary bypass and expected prolonged bypass duration (>180 minutes) will receive standard intraoperative management according to institutional practice versus hemoadsorption device and standard of care. |
| Hemoadsorption Group | Experimental | Participants will receive hemoadsorption therapy using a Jafron HA-60 or HA380 cartridge in addition to standard-of-care versus standard of care, integrated into the cardiopulmonary bypass (CPB) circuit during surgery. The specific cartridge is chosen based on the patient's weight. The device works to filter out inflammatory proteins (cytokines) from the blood while the patient is on the heart-lung machine. This treatment starts at the beginning of the bypass and ends when the bypass is completed. Receives: Device: Hemoadsorption (Jafron HA-60/HA380) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT)
To evaluate changes in IL-6 plasma concentrations over the first 24 hours following the procedure. Analysis will be performed using a linear mixed-effects model (LMM) to capture both between-subject and within-subject variability across repeated time points. This method allows assessment of the overall trajectory of IL-6 and provides a clearer understanding of its temporal pattern throughout the 24-hour post-procedure period.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The LEAT study employs a prospective, single-center, randomized controlled trial design with a parallel-group assignment. This model was chosen to ensure a direct comparison between the intervention and the current gold standard of care. * Randomization \& Allocation: Eligible pediatric patients are assigned to either the intervention or control group in a 1:1 ratio. * Parallel Execution: Participants in the Intervention Group receive hemoadsorption therapy utilizing the Jafron HA-60 or HA380 cartridge, which is integrated directly into the cardiopulmonary bypass (CPB) circuit. Participants in the Control Group receive the standard institutional perioperative care. Both groups are monitored and managed concurrently under identical clinical conditions. * Treatment Duration: The intervention is strictly localized to the intraoperative phase. The hemoadsorption process occurs continuously from the initiation of CPB until the termination of the bypass procedure.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norfaniza Zabidi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Norfaniza Zabidi, Institut Jantung Negara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771491
- Sponsor's protocol ID
- IJNREC/812/2025
- Other IDs
- IJN Foundation, Jafron Biomedical
- Acronym
- LEAT
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT)
- ClinicalTrials.gov ID
- NCT07771491
- Acronym / sponsor ID
- LEAT / IJNREC/812/2025
- Conditions
- Congenital Heart Disease, Open Heart Surgery, Cardiopulmonary Bypass, Endocarditis Acute and Subacute, Cyanotic Heart Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Norfaniza ZabidiUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 18 Aug 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 Localized Evidence of Cytokine Adsorption Therapy (LEAT) study is a prospective, randomized controlled trial conducted at the Institut Jantung Negara in Malaysia. It evaluates the efficacy and safety of using Jafron HA-60 and HA380 hemoadsorption cartridges to reduce systemic inflammation in pediatric patients undergoing major heart surgery.
Objective This study aims to compare the post-operative inflammatory response in children undergoing cardiac procedures treated with or without a cytokine.
Study Population All children < 18 years of age at the time of enrollment who are scheduled to undergo cardiac surgery involving cardiopulmonary bypass (CPB) with an expected duration of >180 minutes.
Methodology This single-center study will randomly assign patients before surgery into 2 groups: 1 group will receive hemoadsorption treatment plus with standard-of-care (intervention group), while the other group will receive standard-of-care (control group) only.
Primary Endpoint:
To evaluate changes in IL-6 plasma concentrations over the first 24 hours following the procedure. Analysis will be performed using a linear mixed-effects model (LMM) to capture both between-subject and within-subject variability across repeated time points. This method allows assessment of the overall trajectory of IL-6 and provides a clearer understanding of its temporal pattern throughout the 24-hour post-procedure period.
Secondary Endpoints:
- Changes cytokines (IL-8, IL-10, IL-1β, and TNF-α) plasma levels over 24 hours
- PELOD-2 score on ICU admission, at 48 hours post ICU admission
- ICU and hospital length of stay
- ICU, hospital, and 28 days mortality
- Mechanical - ventilation (MV) free days at day
- Renal replacement therapy (RRT) free days at day 28
- Vasopressors free days at day 28
- Acute kidney injury
- Bleeding complications
- Post operative liver injury
Data Collection:
Blood samples will be taken at five timepoints: before surgery, at ICU admission, and at 6, 24, and 48 hours post-procedure .
Duration: The study is expected to last 24 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The LEAT study employs a prospective, single-center, randomized controlled trial design with a parallel-group assignment. This model was chosen to ensure a direct comparison between the intervention and the current gold standard of care. * Randomization \& Allocation: Eligible pediatric patients are assigned to either the intervention or control group in a 1:1 ratio. * Parallel Execution: Participants in the Intervention Group receive hemoadsorption therapy utilizing the Jafron HA-60 or HA380 cartridge, which is integrated directly into the cardiopulmonary bypass (CPB) circuit. Participants in the Control Group receive the standard institutional perioperative care. Both groups are monitored and managed concurrently under identical clinical conditions. * Treatment Duration: The intervention is strictly localized to the intraoperative phase. The hemoadsorption process occurs continuously from the initiation of CPB until the termination of the bypass procedure.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants undergoing cardiac surgery with cardiopulmonary bypass and expected prolonged bypass duration (>180 minutes) will receive standard intraoperative management according to institutional practice versus hemoadsorption device and standard of care. |
| Hemoadsorption Group | Experimental | Device: Hemoadsorption (Jafron HA-60/HA380)Participants will receive hemoadsorption therapy using a Jafron HA-60 or HA380 cartridge in addition to standard-of-care versus standard of care, integrated into the cardiopulmonary bypass (CPB) circuit during surgery. The specific cartridge is chosen based on the patient's weight. The device works to filter out inflammatory proteins (cytokines) from the blood while the patient is on the heart-lung machine. This treatment starts at the beginning of the bypass and ends when the bypass is completed. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children (<18 years old at study inclusion)
- Undergoing a cardiac surgery with CPB of expected duration > 180min
- Prophylactic application of HA during CPB for suspected SIRS.
Key exclusion criteria (3 listed)
- Non-ability to gather informed consent from parents or legal representative. Enrolled in conflicting research study
- Off-pump procedure
- Non-steroidal anti-inflammatory treatment in the previous 7 days Pregnancy
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 |
|---|---|---|
| Hemoadsorption (Jafron HA-60/HA380)Participants will receive hemoadsorption therapy using a Jafron HA-60 or HA380 cartridge in addition standard of care integrated into the cardiopulmonary bypass (CPB) circuit during surgery. The specific cartridge is chosen based on the patient's weight. The device works to filter out inflammatory proteins (cytokines) from the blood while the patient is on the heart-lung machine. This treatment starts at the beginning of the bypass and ends when the bypass is completed. | Device | Hemoadsorption Group |
Primary outcome
Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT)
Time frame: 24 Months
To evaluate changes in IL-6 plasma concentrations over the first 24 hours following the procedure. Analysis will be performed using a linear mixed-effects model (LMM) to capture both between-subject and within-subject variability across repeated time points. This method allows assessment of the overall trajectory of IL-6 and provides a clearer understanding of its temporal pattern throughout the 24-hour post-procedure period.
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 18 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Hemoadsorption (Jafron HA-60/HA380) in people with Congenital Heart Disease and Open Heart Surgery, run by Norfaniza Zabidi.
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 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: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Sivakumar Sivalingam (+6032617 8200, sivakumar@ijn.com.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT) (time frame: 24 Months). 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 18 Aug 2026.