Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
NCT ID:
NCT02923206
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02923206
Study Brief:
Protocol Section:
NCT02923206