Usefulness of Extracorporeal Removal of sFLT-1 in Women With Very Early Severe Preeclampsia

NCT02286284 | Terminated Phase 2 DMC

• 1 other identifier: P130928/ N°IDRCB2014-A01044-43
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction Preeclampsia is a multifactorial disease that is responsible of important adverse maternal and perinatal outcomes. Recently, it has been suggested that soluble fms-like tyrosine kinase 1, s-Flt1, induces preeclampsia-like phenotype in experimental models and circulates at elevated levels in human preeclampsia. The aim of our study is to see whether removal of s-Flt1 may improve perinatal death in women with very early severe preeclampsia at less than 26 weeks' gestation Patients and methods Phase II trial. Women with singleton pregnancy having severe preeclampsia at 23-256/7 weeks' gestation. Women under 18 years, with multiples, or severe fetal growth restriction (less than 5th centile), or abnormal fetal heart rate, or maternal complications (abruption, eclampsia, HELLP syndrome, pulmonary edema, DIC, liver hematoma) are excluded from the study. After blood pressure and maternal stabilization, women are approached for information and if they agree, to sign the trial consent. Women have twice weekly extracorporeal removal of s-Flt1 until 34 weeks' gestation. Primary endpoint or success of the procedure: baby alive or alive at 6 months if hospitalized Statistical procedure Simon minimax plan; P0: 60%, P1, 90%, alpha error: 5%, beta power; 90%. First step: number 8 patients. If success equal or less than 5, the study is stopped. Second step: if success of 6 or more, the study is continued for 9 more patients. Overall, a maximum of 17 patients will be included. The final success of extracorporeal removal of s-Flt1 will be considered if 14 or more babies will be alive or alive at 6 months if hospitalized.

Conditions

Preeclampsia

Keywords

Early severe preeclampsia; Angiogenic factor; Apheresis

Outcome Measures

Primary Outcomes (1)

• Baby discharged alive or alive at 6 months if hospitalized

  During the first step (inclusion of 8 patients) analysis is done continuously, and if 3 women have unsuccess primary endpoint, first step and the study are stopped, with a conclusion of failure of the procedure of lipapheresis.

  6 months

Secondary Outcomes (4)

• Pregnancy prolongation and preeclampsia related adverse outcomes

  15 weeks

• Immunoadsorption tolerance for the mother during the session of lipapheresis

  11 weeks

• Foetal immunoadsorption tolerance during the session of lipapheresis

  11 weeks

• Circulating levels of sFlt1, the placental growth factor (PlGF) and soluble endoglin (sEng) until deliverance

  12 weeks

Study Arms (1)

Apheresis arm

EXPERIMENTAL

Apheresis for extracorporal removal of sFlt-1

Device: Apheresis for extracorporal removal of sFlt-1

Interventions

Apheresis for extracorporal removal of sFlt-1 DEVICE

Apheresis arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Severe preeclampsia at less than 26 weeks' gestation
• Singleton pregnancy
• Signed consent

You may not qualify if:

• Multiple pregnancy
• Gestational age at 26 or above weeks' gestation
• Estimated foetal weight at diagnosis \<5th percentile
• Abnormal fetal heart rate at entry, where feasible (\>24 weeks' gestation)
• Maternal complications at diagnosis: Uncontrolled blood pressure, HELLP syndrome, abruption, eclampsia pulmonary edema, renal failure, liver hematoma

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CHIC

Créteil, France

Location

Related Publications (17)

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MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Blood Component Removal

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Bassam HADDAD

  CHIC Creteil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 7, 2014
• Study Start: March 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 22, 2015

Record last verified: 2015-06

Locations

FR (1)