Status:
COMPLETED
Removal of Anti-Angiogenic Proteins in Preeclampsia Before Delivery
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Kaneka Medical America LLC
Conditions:
Preeclampsia
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Preeclampsia is a syndrome that occurs in approximately 3% to 8% of pregnancies and is associated with considerable maternal and neonatal morbidity and mortality. Except for termination of the pregnan...
Detailed Description
The primary objective of this trial is to determine whether short-term apheresis using a dextran sulfate adsorption (DSA) column (Liposorber LA-15 System; the Device) leads to a reduction in circulati...
Eligibility Criteria
Inclusion
- Inclusion Criteria (maternal):
- Signed informed consent in a pregnant woman ages 18 and 45 years hospitalized for pre-term preeclampsia
- Pre-term preeclampsia defined by systolic BP ≥140 mm Hg or ≥90 mm Hg diastolic at or after 23 weeks of gestation or at or before 32 weeks in gestation in a woman with previously normal BP and proteinuria 0.3 grams in a 24-hour specimen or urine protein/creatinine ratio \>0.30.
- sFlt-1/PlGF ratio \>85 (blood levels of sFlt-1 and PlGF determined using CE-approved Roche Diagnostics assays).
- Exclusion Criteria (Maternal and Fetal):
- Maternal:
- Taking any form of angiotensin cascade blocker
- History or diagnosis of pre-existing chronic hypertension (first 3 patients only)
- History of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure or valvular disease
- History or diagnosis of chronic renal disease
- Patients receiving anticoagulation therapy prior to study entry
- Anticipated immediate delivery within 24 hours
- Signs of central nervous system (CNS) dysfunction, including seizures, cerebral edema (CT-scan or MRI)
- History of thyroid disease
- History of liver abnormalities
- Pulmonary edema
- Thrombocytopenia (platelet count \< 100,000/mm3)
- Anemia - hemoglobin \< 8 g/dL
- Evidence of "reverse Doppler" flow on umbilical Doppler
- Placenta previa
- Placental abruption
- Pre-term labor
- Active hepatitis B, C, or tuberculosis infection or HIV positive status
- Any condition that the investigator deems a risk to the patient or fetus in completing the study.
- Any condition which in the opinion of the investigator would necessitate delivery in the next 24 hours
- Fetal characteristic that would exclude the mother from participating:
- Trisomy
- Biophysical profile (BPP) \< 6
- Amniotic fluid index (AFI) \< 5 cm
- Estimated fetal weight (EFW) \< 5th percentile for gestational age (IUGR)
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01404910
Start Date
May 1 2013
End Date
September 1 2015
Last Update
March 16 2017
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02116
2
University Hospital of Cologne (Universitat zu Koln)
Cologne, Germany, 50923
3
University Hospital Leipzig
Leipzig, Germany