NCT04949698

Brief Summary

Early identification of the risk factors of pregnancy-related thrombotic microangiopathies can help us reduce the complications of such patients and increase the survival rate of patients. In addition, it is still controversial whether patients with pregnancy-related thrombotic microvessels should receive plasma therapy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

June 29, 2021

Last Update Submit

June 29, 2021

Conditions

Keywords

pregnancythrombotic microangiopathies

Outcome Measures

Primary Outcomes (1)

  • TMA happen

    pregnancy associated thrombotic microangiopathy happen or not at 28th day after ICU admission

    28th day after ICU admission

Secondary Outcomes (3)

  • renal function

    28th day after ICU admission

  • platelet level

    28th day after ICU admission

  • survival rate

    28th day after ICU admission

Study Arms (3)

No TMA

parturients without thrombotic microangiopathies

Device: plasma exchange

TMA with plasma exchange

parturients with thrombotic microangiopathies, and treated with plasma exchange

Device: plasma exchange

TMA without plasma exchange

parturients with thrombotic microangiopathies, but not treated with plasma exchange

Device: plasma exchange

Interventions

Plasma exchange was performed daily for five times or until platelet level returned to normal

No TMATMA with plasma exchangeTMA without plasma exchange

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility DetailsThis study is for puerpera with or without TMA, so patients should be female only
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant patients admitted to the Department of critical care medicine, the Third Hospital of Peking University from 2015 to 2019

You may qualify if:

  • Pregnant patients admitted to the Department of critical care medicine, the Third Hospital of Peking University from 2015 to 2019

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thrombotic Microangiopathies

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

ThrombocytopeniaBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeuticsPlasmapheresisBlood Component RemovalSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Min Yi, chief physician

    Peking University Third Hospital

    STUDY DIRECTOR

Central Study Contacts

Min Yi, chief physician

CONTACT

Tiehua Wang, deputy chief doctors

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 2, 2021

Study Start

August 1, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

July 2, 2021

Record last verified: 2021-06