Pregnancy-related Thrombotic MicroangiopathiesNCT04949698
Risk Factors and the Effect of Plasma Exchange on Prognosis of Pregnancy-related Thrombotic Microangiopathies
An observational study of Pregnancy-related Thrombotic Microangiopathies, run by Peking University Third Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pregnancy-related Thrombotic Microangiopathies
- What is being tested?
- plasma exchange
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Pregnant patients admitted to the Department of critical care medicine, the Third Hospital of Peking University from 2015 to 2019
Who may be able to join
- Pregnant patients admitted to the Department of critical care medicine, the Third Hospital of Peking University from 2015 to 2019
Who cannot join
- NO
Trial locations and contacts
No sites are listed yet.
About this study
Official title: "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.
Read the 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."
- Being tested
- plasma exchange
- Keywords
- pregnancy, thrombotic microangiopathies
- Medical subject headings
- Thrombotic Microangiopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma exchangeDevice
Plasma exchange was performed daily for five times or until platelet level returned to normal
| Study group | Role | What they receive |
|---|---|---|
| No TMA | parturients without thrombotic microangiopathies Receives: Device: plasma exchange | |
| TMA with plasma exchange | parturients with thrombotic microangiopathies, and treated with plasma exchange Receives: Device: plasma exchange | |
| TMA without plasma exchange | parturients with thrombotic microangiopathies, but not treated with plasma exchange Receives: Device: plasma exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMA happen
pregnancy associated thrombotic microangiopathy happen or not at 28th day after ICU admission
Measured: 28th day after ICU admission
Secondary outcomes (3)
renal function
renal function at 28th day after ICU admission
Measured: 28th day after ICU admission
platelet level
platelet level at 28th day after ICU admission
Measured: 28th day after ICU admission
survival rate
survival rate at 28th day after ICU admission
Measured: 28th day after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy-related Thrombotic MicroangiopathiesStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Yi, chief physician, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949698
- Sponsor's protocol ID
- LM2020304
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Risk Factors for Pregnancy-related Thrombotic Microangiopathies Retrospective Study of the Effect of Plasma Exchange on Prognosis of Pregnancy-related Thrombotic Microangiopathies"
- ClinicalTrials.gov ID
- NCT04949698
- Acronym / sponsor ID
- LM2020304
- Keywords
- pregnancy, thrombotic microangiopathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No TMA | – | Device: plasma exchangeparturients without thrombotic microangiopathies |
| TMA with plasma exchange | – | Device: plasma exchangeparturients with thrombotic microangiopathies, and treated with plasma exchange |
| TMA without plasma exchange | – | Device: plasma exchangeparturients with thrombotic microangiopathies, but not treated with plasma exchange |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant patients admitted to the Department of critical care medicine, the Third Hospital of Peking University from 2015 to 2019
Key inclusion criteria (1 listed)
- Pregnant patients admitted to the Department of critical care medicine, the Third Hospital of Peking University from 2015 to 2019
Key exclusion criteria (1 listed)
- NO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plasma exchangePlasma exchange was performed daily for five times or until platelet level returned to normal | Device | No TMA, TMA with plasma exchange, TMA without plasma exchange |
Primary outcome
TMA happen
Time frame: 28th day after ICU admission
pregnancy associated thrombotic microangiopathy happen or not at 28th day after ICU admission
3 secondary outcomes
renal function
Time frame: 28th day after ICU admission
platelet level
Time frame: 28th day after ICU admission
survival rate
Time frame: 28th day after ICU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Yi, chief physician study director
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy-related Thrombotic Microangiopathies, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Yi, chief physician (+86 15611963370, minyi0101@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TMA happen (time frame: 28th day after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.