Blood Collection to Validated New Therapeutics Strategies Against Preeclampsia

Preeclampsia Clinical Trial

— APHERESE  

Official title:

New Therapeutic Strategy Against Preeclampsia: Angiogenic Switch to Physiological State by Extracorporeal Removal of sFlt-1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188900
• Other study ID #: SC3455
• Status: Completed
• Start date: June 12, 2017
• Est. completion date: June 12, 2019

Study information

• Verified date: September 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of the study is to setup a collection of maternal plasma and serum from patients with preeclampsia and normal pregnancy for in vitro validation of new therapeutics based on extra-corporal removal of sFlt-1

Description:

A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP) :

• Between 20WG and 23WG+6D : 20 patients with PE and 30 patients with NP

• Between 24WG and 27WG+6D : 20 patients with PE and 30 patients with NP

• Between 28WG and 31WG+6D : 20 patients with PE and 30 patients with NP

• Between 32WG and 35WG+6D : 20 patients with PE and 30 patients with NP

• Between 36WG and 40WG+6D : 20 patients with PE and 30 patients with NP

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: June 12, 2019
• Est. primary completion date: June 12, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age from 18 to 50 years old

• Singleton pregnancies between 20 and 41 weeks of gestation

• Preeclampsia

• Normal pregnancy

Exclusion Criteria:

• Age<18

• Infectious disease: HIV, HBV or HCV

• Multiple pregnancies

• Opposition of the patient

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Biological:
• A collection of maternal plasma and serum
A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP)

Locations

Country	Name	City	State
France	Hopital Cochin	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	INSERM UMR-S 1139

Country where clinical trial is conducted

France, 

References & Publications (4)

Levine RJ, Maynard SE, Qian C, Lim KH, England LJ, Yu KF, Schisterman EF, Thadhani R, Sachs BP, Epstein FH, Sibai BM, Sukhatme VP, Karumanchi SA. Circulating angiogenic factors and the risk of preeclampsia. N Engl J Med. 2004 Feb 12;350(7):672-83. Epub 2004 Feb 5. — View Citation

Thadhani R, Hagmann H, Schaarschmidt W, Roth B, Cingoez T, Karumanchi SA, Wenger J, Lucchesi KJ, Tamez H, Lindner T, Fridman A, Thome U, Kribs A, Danner M, Hamacher S, Mallmann P, Stepan H, Benzing T. Removal of Soluble Fms-Like Tyrosine Kinase-1 by Dextran Sulfate Apheresis in Preeclampsia. J Am Soc Nephrol. 2016 Mar;27(3):903-13. doi: 10.1681/ASN.2015020157. Epub 2015 Sep 24. — View Citation

Trapiella-Alfonso L, Alexandre L, Fraichard C, Pons K, Dumas S, Huart L, Gaucher JF, Hebert-Schuster M, Guibourdenche J, Fournier T, Vidal M, Broutin I, Lecomte-Raclet L, Malaquin L, Descroix S, Tsatsaris V, Gagey-Eilstein N, Lecarpentier E. VEGF (Vascula — View Citation

Tsatsaris V, Goffin F, Munaut C, Brichant JF, Pignon MR, Noel A, Schaaps JP, Cabrol D, Frankenne F, Foidart JM. Overexpression of the soluble vascular endothelial growth factor receptor in preeclamptic patients: pathophysiological consequences. J Clin Endocrinol Metab. 2003 Nov;88(11):5555-63. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ratio sFlt-1/PlGF	measurement of of sFlT-1 and PlGF	Day 0
Secondary	Kinetics of these ratios sFlt-1/PlGF during pregnancy	measurement of of sFlT-1 and PlGF at many times	until 5 month