Jafron Cytokine Adsorber During Pediatric Open-Heart Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Screened-to-enrolled patients' ratio and number of intervention delivery group
研究概览
简要总结
This prospective single-center randomized controlled trial aims at evaluating the safety and feasibility of an hemoadsorption protocol using Jafron HA-60 during cardio-pulmonary bypass in 20 pediatric patients undergoing open-heart surgery.
详细描述
Cardiopulmonary bypass (CPB) is an extracorporeal system that temporarily takes over the functions of the heart and lungs by diverting blood during cardiac surgery. However, the use of CPB is know to trigger a significant systemic inflammatory response, largely mediated by cytokines. In severe cases, this response may result in vasoplegia, hypotension, and subsequent organ dysfunction. Several pharmacological interventions have been investigated to reduce the incidence and severity of this post-surgical inflammatory response, but results have been very mitagated. Among emerging strategies, the pre-procedural removal of circulating cytokines through hemoadsorption represents a promising approach. In particular the use of a HA-60® cartridge (Jafron Biomedical, Guangdong, China) integrated into the CPB circuit may help attenuate the inflammatory cascade.
This pilot study is designed to evaluate the feasibility and safety of implementing an hemoadsorption protocol during cardiopulmonary bypass in a pediatric population. Pediatric patients scheduled for complex cardiac procedures will be enrolled before surgery and randomly assigned in a 1:1 ratio to either receive hemoadsorption therapy with standard care (intervention group) or standard care alone (control group).
In the intervention group, an HA-60® hemoadsorption cartridge will be integrated into the CPB circuit during setup and used throughout the duration of the bypass. Four blood samples will be collected : Post-anestesia induction, CPB termination, ICU admission, and 24 hours post ICU admission-to measure cytokine levels. Clinical data, including vital signs, organ support, demographics, and medical history, will be recorded in the electronic medical records.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ≤ 10 years old at study inclusion
- •Children weighing at least 5 kg at study inclusion
- •Planned for open-heart cardiac surgery with CPB-time ≥ 120 min and aortic clamping.
- •Informed consent obtained from parent(s)/legal representative
排除标准
- •Children having an indication to receive hemoadsorption during CPB for drugs removal or other medically justified reason
- •Previous enrolment into the current study
- •Off-pump procedure
- •Chronic immunosuppression (chronic corticosteroid therapy, chemotherapy, anti-leucocyte drugs, TNF blockers or else)
- •Known allergy to heparin or heparin induced thrombocytopenia.
- •Severe thrombopenia (platelets count before surgery < 20G/L)
- •Parent(s)/legal representative not able to understand/read French and/or English
- •Participation in another conflicting research study
研究组 & 干预措施
Hemoadsorption
Cardiopulmonary bypass (CPB) will be conducted as per institutional protocols and an HA-60® cartridge (Jafron Biomedical, Guangdong, China) will be inserted within the circuit for hemoadsorption.
干预措施: Hemoadsorption (Device)
Control
Cardiopulmonary bypass will be conducted as per institutional protocols, without hemoadsorption (standard-of-care)
结局指标
主要结局
Screened-to-enrolled patients' ratio and number of intervention delivery group
时间窗: Start CPB, End CPB, 1 Day and aftrer 28 day
* Screened-to-enrolled patients' ratio ≥ 0.3\* * ≥ 80% of intervention delivery in intervention group (number of patients who received hemoadsorption \> 50% of CPB duration) * Duration of recruitment: no more than 36 months (approximately 0.56 patient per month) * \<5% of study interruptions attribuable to insufficiant resources or logistical constraints \*(Previous pilot studies in intervention contexts report screened-to-enrolled patient ratios of approximately 0.30-0.50; therefore a threshold of ≥ 0.30 has been chosen as a minimal acceptable benchmark for feasibility.)
Device-related adverse events
时间窗: From beginning of cardiopulmonary bypass to 7 days after ICU admission or ICU discharge wichever occurs first.
Assessed with the occurrence of 4 categories of adverse events in each group: Device-related complications: • Technical failure to perform the treatment: thrombosis of the cartridge, circuit leak or inability to perform the treatment for all CPB duration. Tolerance: * New allergic or anaphylactoid reaction (stage ≥ 2 by H. L. Mueller \[5\]) * New fever (\> 39°C for more than an hour). Bleeding/haematological complications\*: * Intracranial haemorrhages * Need for massive transfusion (\>10mL/kg/h during more than 3 consecutive hours) * Incidence of new thrombocytopenia (mild \<150 G/L, moderate, \<100 G/L severe \< 50 G/L) \*(We will consider separately bleeding/haematological complications occurring during the procedure (from CPB initiation to ICU admission) and those occurring from ICU admission to day 7 or ICU discharge, whichever occurs first.) All other event judged relevant by the investigator (i.e. cardiac arrest). NB: "New" means not present at the time of CPB initiation
次要结局
- Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score at 24 hours(Measured between post-anestesia induction and 24 hours post ICU-admission)
- Pediatric Logistic Organ Dysfunction-2 (PELOD-2) worst value(Within 4 hours of ICU admission)
- Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score at 48 hours(Measured between 24 hours and 48 hours after ICU admission)
- Change in cytokine levels compared to baseline(at the end of CPB, at the admission in ICU and 24 hours after ICU admission)
- ICU and hospital lenght of stay(At time of hospital discharge, an average 20 days after ICU admission)
- ICU, hospital, and 28 days (from ICU admission) mortality(At time of hospital discharge, an average 20 days after ICU admission and up to 28 days after ICU admission)
- Days alive without respiratory support(At day 28 from ICU admission)
- Days alive without renal replacement therapy(At day 28 from ICU admission])
- Days alive without vasopressors(At day 28 from ICU admission])
- Days alive without ECMO support(At day 28 from ICU admission)
- Post-operative complications(At time of ICU discharge, up to 7 days after ICU admission)
研究者
Antoine Schneider
Principal Investigator
Centre Hospitalier Universitaire Vaudois