Proof-of-Concept Trial on Selective Removal of SFlt-1 in Pregnant Women with Preeclampsia Via Apheresis

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.