Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis (SAVE)

 Eclampsia / Posted 9 months ago

Brief 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.
  • Inclusion Criteria :
    • Ages Eligible for Study: 18 Years to 45 Years (Adult)
    • Sexes Eligible for Study: All
    • Accepts Healthy Volunteers: Yes
    • 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;
    • 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.
  • Study start date : September 2016
  • Study end date : February 2023
  • Wales-Based Study Contact : Please speak to your clinician
  • Principal Investigator : Manu Vatish, MD (John Radcliffe Hospital)
Contact details

John Radcliffe Hospital, OxfordOxford,England,OX3 9DU

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