Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis (SAVE)
Eclampsia / Posted 5 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)