A Feasibility Study to Evaluate the Safety of the KNP-1000 Apheresis System in Severe Preeclampsia

Exclusion Criteria

• •A participant will be excluded from the investigation if any of the following maternal or fetal criteria are met.
• •1. 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.
• •2. Documented history of proteinuria prior to pregnancy or prior to 20 weeks of gestation.
• •3. Taking any form of angiotensin cascade blocker or angiotensin-converting enzyme (ACE) inhibitor at time of enrollment.
• •4. Documented history of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease.
• •5. Actively receiving therapeutic anticoagulation therapy or within the therapeutic window after ceasing anticoagulation therapy at the time of enrollment.
• •6. Any condition which, in the opinion of the Investigator, would necessitate immediate delivery within 24 hours.
• •7. 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).
• •8. Confirmed or suspected diagnosis of pulmonary edema at time of enrollment.
• •9. Diagnosis of HELLP syndrome.
• •10. Thrombocytopenia (platelet count \< 100,000/mm3) at time of enrollment.
• •11. Anemia defined as hemoglobin \< 8 g/dL at time of enrollment.
• •12. 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.
• •13. Diagnosis of placenta previa during the current gestation period.
• •14. Preterm labor at or before time of screening.
• •15. Documented medical history of active hepatitis B virus, hepatitis C virus (HCV), syphilis, tuberculosis infection, or human immunodeficiency virus (HIV) positive status.
• •16. Any condition that the Investigator deems a risk to the study participant or fetus in completing the investigation.
• •17. Hypersensitivity to dextran sulfate cellulose or heparin.
• •18. Multiple gestation.
• •19. Documented history of familial hypercholesterolemia.
• •20. Suspicion or diagnosis of placental abruption during the current gestation.
• •21. 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.
• •22. Patients who have participated in another clinical trial within 6 months prior to enrollment.
• •1. Documented record of chromosomal anomalies.
• •2. Identifiable structural fetal abnormalities present at time of screening or a record of such abnormalities prior to enrollment.
• •3. Oligohydramnios, defined as Amniotic fluid index (AFI) less than 5 cm when measured using the four-quadrant method at time of enrollment.
• •4. Fetal growth restriction (FGR) defined as estimated fetal weight (EFW) below the 5th percentile for gestational age.