Can a blood filter help mothers with severe preeclampsia carry longer?
NCT ID NCT06580405
First seen Aug 28, 2026 · Last updated Aug 28, 2026
Summary
This trial tests whether a device called the KNP-1000 apheresis system is safe for pregnant women with severe preeclampsia and their babies. The device filters the mother's blood to remove a protein linked to the condition. Researchers will enroll about 13 women between 23 and 32 weeks of pregnancy and monitor for complications in both mother and baby. The main goal is safety, with a secondary look at whether treatment can prolong the pregnancy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KNP-1000 apheresis system, a device that filters the mother's blood to remove a protein called sFlt-1
- What this could lead to
- If safe and effective, this approach could help women with severe preeclampsia carry their pregnancies longer, reducing risks from premature birth.
- What could go wrong
- This is a very small feasibility study focused on safety, not proof of benefit. The device may not meaningfully improve outcomes, and there are inherent risks to both mother and fetus from the procedure and the condition itself.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 13 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: A participant is deemed suitable for inclusion in the investigation if she meets the following criteria: 1. Pregnant woman ≥ 23 0/7 and \< 32 0/7 weeks gestation, aged 18 to 45 years, hospitalized for preeclampsia at time of enrollment. 2. 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. 3. Proteinuria, defined as ≥ 300 mg protein in a 24-hour urine collection or ≥ 0.3 protein/creatinine ratio. 4. Provision of signed and dated informed consent form. Exclusion Criteria: A participant will be excluded from the investigation if any of the following maternal or fetal criteria are met. Maternal Exclusion Criteria: 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. Fetal Exclusion Criteria: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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