NCT06580405尚未招募不适用
A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Patients With Preeclampsia With Severe Features
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 13
- 主要终点
- Antepartum maternal and fetal device-related serious adverse events
研究概览
简要总结
The study will primarily evaluate safety of the KNP-1000 apheresis system for pregnant women and their fetuses diagnosed with preeclampsia with severe features between 23- and 32-weeks' gestation (very preterm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A participant is deemed suitable for inclusion in the investigation if she meets the following criteria:
- •Pregnant woman ≥ 23 0/7 and < 32 0/7 weeks gestation, aged 18 to 45 years, hospitalized for preeclampsia at time of enrollment.
- •Severe hypertension ever defined by resting systolic BP ≥ 160 mm Hg and/or diastolic BP ≥ 110 mm Hg on two occasions measured at least 4 hours apart.
- •Proteinuria, defined as ≥ 300 mg protein in a 24-hour urine collection or ≥ 0.3 protein/creatinine ratio.
- •Provision of signed and dated informed consent form.
排除标准
- •A participant will be excluded from the investigation if any of the following maternal or fetal criteria are met.
- •Maternal Exclusion Criteria:
- •Documented history of chronic hypertension, defined as systolic BP ≥ 140mmHg and/or systolic BP ≥ 90 mmHg before pregnancy or prior to 20 weeks of gestation.
- •Documented history of proteinuria prior to pregnancy or prior to 20 weeks of gestation.
- •Taking any form of angiotensin cascade blocker or angiotensin-converting enzyme (ACE) inhibitor at time of enrollment.
- •Documented history of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease.
- •Actively receiving therapeutic anticoagulation therapy or within the therapeutic window after ceasing anticoagulation therapy at the time of enrollment.
- •Any condition which, in the opinion of the Investigator, would necessitate immediate delivery within 24 hours.
- •Signs or history of cerebral nervous system dysfunction, including seizures, cerebral edema (previously confirmed by computed tomography scan or magnetic resonance imaging per medical records).
- •Confirmed or suspected diagnosis of pulmonary edema at time of enrollment.
- •Diagnosis of HELLP syndrome.
- •Thrombocytopenia (platelet count < 100,000/mm3) at time of enrollment.
- •Anemia defined as hemoglobin < 8 g/dL at time of enrollment.
- •Absent or reverse flow on umbilical Doppler ultrasound exam at the time of screening, or documented history of negative or reverse flow during the current gestation period.
- •Diagnosis of placenta previa during the current gestation period.
- •Preterm labor at or before time of screening.
- •Documented medical history of active hepatitis B virus, hepatitis C virus (HCV), syphilis, tuberculosis infection, or human immunodeficiency virus (HIV) positive status.
- •Any condition that the Investigator deems a risk to the study participant or fetus in completing the investigation.
- •Hypersensitivity to dextran sulfate cellulose or heparin.
- •Multiple gestation.
- •Documented history of familial hypercholesterolemia.
- •Suspicion or diagnosis of placental abruption during the current gestation.
- •Patients who have received the drug treatment not recommended by the American College of Obstetricians and Gynecologists (ACOG) practice bulletin Gestational Hypertension and Preeclampsia (the clinical management guidelines) within 6 months prior to enrollment.
- •Patients who have participated in another clinical trial within 6 months prior to enrollment.
- •Fetal Exclusion Criteria:
- •Documented record of chromosomal anomalies.
- •Identifiable structural fetal abnormalities present at time of screening or a record of such abnormalities prior to enrollment.
- •Oligohydramnios, defined as Amniotic fluid index (AFI) less than 5 cm when measured using the four-quadrant method at time of enrollment.
- •Fetal growth restriction (FGR) defined as estimated fetal weight (EFW) below the 5th percentile for gestational age.
研究组 & 干预措施
KNP-1000 Apheresis System
Experimental
Participants are to be treated with the system up to 2 times per week, continuing through delivery or 34 weeks of pregnancy, whichever comes first.
干预措施: KNP-1000 Apheresis System (Device)
结局指标
主要结局
Antepartum maternal and fetal device-related serious adverse events
时间窗: Until date of delivery
Rate of antepartum maternal and fetal device-related serious adverse events
Maternal, fetal, and neonatal mortality
时间窗: Until end of follow-up (2 years)
Rate of maternal, fetal, and neonatal mortality
Fetal complications
时间窗: Until date of delivery
Incidence rate of fetal complications
Postpartum maternal and neonatal device-related serious adverse events
时间窗: Following delivery until end of follow-up (2 years)
Rate of postpartum maternal and neonatal device-related serious adverse events
Neonatal morbidities associated with premature delivery
时间窗: Following delivery until discharge or 6 weeks after delivery, whichever occurs first
Incidence rate of neonatal morbidities associated with premature delivery
Neonatal intensive care unit (NICU) admissions
时间窗: From date of NICU admission until the date of NICU discharge, assessed up to 24 months
Rate of NICU admissions and length of stay
Obstetric complication
时间窗: Until discharge or 6 weeks after delivery, whichever occurs first
Incidence rate of obstetric complication
次要结局
- Prolongation of pregnancy(Until date of delivery)
- Fetal umbilical artery flow(Until the date of delivery, an average of 3 months)
- Fetal growth restriction(Until date of delivery)
- Umbilical artery and vein blood gases(At date of delivery)
- Bayley Scales(At 6, 12, and 24 months after delivery)
- Maternal systolic blood pressure(Until discharge or 6 weeks after delivery, whichever occurs first)
- Uterine artery flow(Until the date of delivery, an average of 3 months)
- Maternal diastolic blood pressure(Until discharge or 6 weeks after delivery, whichever occurs first)
- Maternal proteinuria(Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months)
- Gestational age of the neonate at delivery(At date of delivery)
- Amniotic fluid volume(Until the date of delivery, an average of 3 months)
- Maternal low-density lipoprotein cholesterol (LDL-C) levels(Until discharge or 6 weeks after delivery, whichever occurs first, an average of 4 months)
- APGAR scores(At date of delivery)
- Weight of neonate at delivery(At date of delivery)
- Body weight of infant(Following delivery until end of follow-up (2 years))
- Body length and head circumference of infant(Following delivery until end of follow-up (2 years))
研究者
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