Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT) (LEAT)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sivakumar Sivalingam
- Phone Number: +6032617 8200
- Email: sivakumar@ijn.com.my
Study Contact Backup
- Name: Irni Yusnida Md Rashid
- Phone Number: +6032617 8385
- Email: irni@ijn.com.my
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
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.
|
|
|
Experimental: Hemoadsorption Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
24 Months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IJNREC/812/2025
- IJN Foundation (Other Grant/Funding Number: Institut Jantung Negara Foundation (IJNF))
- Jafron Biomedical (Other Grant/Funding Number: Jafron Biomedical Co., Ltd., China)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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