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

NCT07771491 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-18

No results posted yet for this study

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 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.

Conditions

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Norfaniza Zabidi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2028-10-31
Completion
2028-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07771491 on ClinicalTrials.gov