APHERESE: Blood Collection to Validated New Therapeutics Strategies Against Preeclampsia

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT03188900
• Collaborator: INSERM UMR-S 1139 (Other)
• Enrollment: 236
• Location: 1
• Actual Duration (Months): 24
• Patients Per Site Per Month: 9.8

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia	Biological: A collection of maternal plasma and serum

Detailed 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

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 236 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: New Therapeutic Strategy Against Preeclampsia: Angiogenic Switch to Physiological State by Extracorporeal Removal of sFlt-1
• Actual Study Start Date: Jun 12, 2017
• Actual Primary Completion Date: Jun 12, 2019
• Actual Study Completion Date: Jun 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
preeclampsia pregnancy with preeclampsia	Biological: A collection of maternal plasma and serum; A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP)
control pregnancy without preeclampsia	Biological: A collection of maternal plasma and serum; A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP)

Outcome Measures

Primary Outcome Measures

1. ratio sFlt-1/PlGF [Day 0]

   measurement of of sFlT-1 and PlGF

Secondary Outcome Measures

1. Kinetics of these ratios sFlt-1/PlGF during pregnancy [until 5 month]

   measurement of of sFlT-1 and PlGF at many times

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Cochin	Paris		France	75014

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris
• INSERM UMR-S 1139

Investigators

• Study Director: Edouard Lecarpentier, MD, PhD, Centre Hospitalier Intercommunal de Créteil

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT03188900
• Other Study ID Numbers: SC3455
• First Posted: Jun 16, 2017
• Last Update Posted: Sep 27, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: Preeclampsia; apheresis; sflt-1
• Additional relevant MeSH terms: Pre-Eclampsia

Study Results

No Results Posted as of Sep 27, 2021