Risk Factors and the Effect of Plasma Exchange on Prognosis of Pregnancy-related Thrombotic Microangiopathies

• Conditions: Pregnancy-related Thrombotic Microangiopathies
• Interventions: Device: plasma exchange

• Registration Number: NCT04949698
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

"Objective: To evaluate the risk factors of pregnancy-related thrombotic microangiopathies and the effect of plasma exchange on the prognosis (recovery status of renal function, recovery status of platelets, survival or death within 28 days).

Design: A retrospective analysis of pregnant patients admitted to the ICU from 2015 to 2019. According to the outcome indicator of the occurrence of pregnancy-related thrombotic microangiopathies, they were divided into thrombotic microangiopathies group and non-thrombotic microangiopathies group. Patients in the pregnancy-related thrombotic microangiopathy group were divided into plasma exchange combined non-plasma exchange group according to whether they received plasma exchange. Collect the clinical data of the patients, and analyze the data using SPSS 1 7.0 statistical software package. The measurement data were compared by paired t test and one-way analysis of variance; the count data were compared by χ2 test. Compare the differences of the indicators between the two groups and analyze the risk factors of pregnancy-related thrombotic microangiopathies. Then compare whether there is a difference in the prognosis between the plasma exchange group and the non-plasma exchange group."

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-06-29
• Last Update Submitted: 2021-06-29
• Study First Posted: 2021-07-02
• Last Update Posted: 2021-07-02
• Study Start: 2021-08-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

• NO

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TMA with plasma exchange	plasma exchange	parturients with thrombotic microangiopathies, and treated with plasma exchange
TMA without plasma exchange	plasma exchange	parturients with thrombotic microangiopathies, but not treated with plasma exchange
No TMA	plasma exchange	parturients without thrombotic microangiopathies

Primary Outcome Measures

Name	Time	Method
TMA happen	28th day after ICU admission	pregnancy associated thrombotic microangiopathy happen or not at 28th day after ICU admission

Secondary Outcome Measures

Name	Time	Method
survival rate	28th day after ICU admission	survival rate at 28th day after ICU admission
renal function	28th day after ICU admission	renal function at 28th day after ICU admission
platelet level	28th day after ICU admission	platelet level at 28th day after ICU admission