proof-of-concept trial on selective removal of sflt-1 in pregnant women with preeclampsia via apheresis

Conditions: Preeclampsia

Summary: this clinical investigation is a medical device trial to examine the safety and efficacy of therasorb sflt-1 adsorber treatment of pregnant patients with preeclampsia.


Eligibility criteria:
reduced criteria! phase 0 inclusion criteria: * age ≥18 and ≤45 years; * male or female; * female subjects of childbearing potential must have a negative serum pregnancy test result at screening and practice two reliable methods of contraception throughout the study. exclusion criteria: * dysfunction of cerebral nervous system and/or heart disease; * history of preexisting chronic renal disease; * treatment with ace inhibitors; * therapeutic full anticoagulation therapy prior to trial entry; * liver abnormalities; * clinically significant pulmonary edema and/or thrombocytopenia and/or anemia; * active hepatitis b, c, or tuberculosis infection or hiv infection * hypersensitivity to heparin and/or citrate; * indications that prohibit transient anticoagulation using heparin and/or acd-a-solutions; * known intolerance to extracorporeal procedures in general or towards one of the individual excipients or towards other supporting agents; * drug or alcohol abuse within the last 2 years; * lack of compliance of subject; * history or diagnosis of severe periodontitis; phase a and b inclusion criteria: * age \>18 and ≤45 years ; * pregnant woman with pre-term preeclampsia * sflt-1/plgf ratio ≥85 ; * sflt-1 level of ≥ 8000pg/ml exclusion criteria: maternal exclusion criteria * history of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure or valve disease; * history of preexisting chronic renal disease (ckd stage \>3a, egfr ≤45ml/min/1.73m²); * treatment with ace inhibitors; * therapeutic full anticoagulation therapy prior to trial entry; * signs or history of clinically significant cerebral nervous system dysfunction; * history of clinically significant liver abnormalities; * clinically significant pulmonary edema and/or thrombocytopenia and/or anemia; * active hepatitis b, c, tuberculosis infection or hiv-positive status; * any condition that the investigator deems a risk to the patient or fetus in completing the trial; * indications that prohibit transient anticoagulation using heparin and/or acd-a-solutions; * drug or alcohol abuse within the last 2 years; * lack of compliance of patient; * known intolerance to extracorporeal procedures in general or to one of the excipients or other supporting agents; * hypersensitivity to heparin and/or citrate; * \< 30 0/7 weeks of gestation and abnormal ctg and/or abnormal ductus venosus doppler flow, * ≥30 0/7 weeks of gestation and doppler evidence of umbilical artery absent or reversed end-diastolic velocity (aredv); * various placental exclusion criteria; * multiple pregnancy * history or diagnosis of severe periodontitis fetal exclusion criteria * any known trisomy; * amniotic fluid index \<5cm (greatest single pocket \<2cm); * estimated fetal weight \<3rd percentile for gestational age; * fetus which are at high risk of heart disease; * fetus with congenital heart defect; * fetal signs of bleeding; * hydrops fetalis; * pathological fetal doppler flow of the ductus venosus (absent a-wave in two measurements); * evidence of severe fetal malformations; * known infection of fetus; * known severe anemia.

Keywords: apheresis pregnancy pre-eclampsia pe sflt-1 pre-term