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

Prior treatment

• 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.
• Actively receiving therapeutic anticoagulation therapy or within the therapeutic window after ceasing anticoagulation therapy at the time of enrollment.
• 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).
• 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:
• Identifiable structural fetal abnormalities present at time of screening or a record of such abnormalities prior to enrollment.

Other illness

• Documented history of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease.
• Any condition which, in the opinion of the Investigator, would necessitate immediate delivery within 24 hours.
• Diagnosis of HELLP syndrome.
• 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.
• 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.
• Documented history of familial hypercholesterolemia.

Lab values

• Thrombocytopenia (platelet count \< 100,000/mm3) at time of enrollment.
• Anemia defined as hemoglobin \< 8 g/dL at time of enrollment.

Age

• Fetal growth restriction (FGR) defined as estimated fetal weight (EFW) below the 5th percentile for gestational age.

Other

• A participant will be excluded from the investigation if any of the following maternal or fetal criteria are met.
• Maternal Exclusion Criteria:
• Confirmed or suspected diagnosis of pulmonary edema at time of enrollment.
• Diagnosis of placenta previa during the current gestation period.
• Preterm labor at or before time of screening.
• Multiple gestation.
• Suspicion or diagnosis of placental abruption during the current gestation.
• Documented record of chromosomal anomalies.
• Oligohydramnios, defined as Amniotic fluid index (AFI) less than 5 cm when measured using the four-quadrant method at time of enrollment.

• 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.