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

"Risk Factors for Pregnancy-related Thrombotic Microangiopathies Retrospective Study of the Effect of Plasma Exchange on Prognosis of Pregnancy-related Thrombotic Microangiopathies"

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy-related Thrombotic Microangiopathies
• Intervention / Treatment: Device: plasma exchange

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Min Yi, chief physician; Phone Number: +86 15611963370; Email: minyi0101@aliyun.com
• Study Contact Backup: Name: Tiehua Wang, deputy chief doctors; Phone Number: +86 15611963378; Email: Tiehua0326@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• NO

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No TMA; parturients without thrombotic microangiopathies	Device: plasma exchange; Plasma exchange was performed daily for five times or until platelet level returned to normal
TMA with plasma exchange; parturients with thrombotic microangiopathies, and treated with plasma exchange	Device: plasma exchange; Plasma exchange was performed daily for five times or until platelet level returned to normal
TMA without plasma exchange; parturients with thrombotic microangiopathies, but not treated with plasma exchange	Device: plasma exchange; Plasma exchange was performed daily for five times or until platelet level returned to normal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TMA happen	pregnancy associated thrombotic microangiopathy happen or not at 28th day after ICU admission	28th day after ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
renal function	renal function at 28th day after ICU admission	28th day after ICU admission
platelet level	platelet level at 28th day after ICU admission	28th day after ICU admission
survival rate	survival rate at 28th day after ICU admission	28th day after ICU admission

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Director: Min Yi, chief physician, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2021
• Primary Completion (ANTICIPATED): August 1, 2022
• Study Completion (ANTICIPATED): August 1, 2022

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (ACTUAL): July 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: pregnancy; thrombotic microangiopathies
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Hematologic Diseases; Thrombocytopenia; Blood Platelet Disorders; Vascular Diseases; Thrombotic Microangiopathies
• Other Study ID Numbers: LM2020304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No