Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT)

Sponsor
Norfaniza Zabidi
Study ID
NCT07771491
Status
Not Yet Recruiting

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Conditions

  • Cardiopulmonary Bypass
  • Congenital Heart Disease
  • Cyanotic Heart Disease
  • Endocarditis Acute and Subacute
  • Open Heart Surgery

Eligibility Criteria

Sex
ALL
Age
0 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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: 1. Changes cytokines (IL-8, IL-10, IL-1β, and TNF-α) plasma levels over 24 hours 2. PELOD-2 score on ICU admission, at 48 hours post ICU admission 3. ICU and hospital length of stay 4. ICU, hospital, and 28 days mortality 5. Mechanical - ventilation (MV) free days at day 6. Renal replacement therapy (RRT) free days at day 28 7. Vasopressors free days at day 28 8. Acute kidney injury 9. Bleeding complications 10. 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.

Key Dates

First listed
Aug 18, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT) [ Time Frame: 24 Months ]

Central Contacts

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