Cardiogenic ShockNCT04144660
"Treatment Use of ECMO In Pregnancy or Peripartum Patient."
An observational study of Cardiogenic Shock and Peripartum Cardiomyopathy, run by Sarah Thordsen at 1 site in United States.
Trial summary
The goal of this study is to describe the use of ECMO (Extracorporeal Membrane Oxygenation) in the pregnant or peripartum patient. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiogenic Shock, Peripartum Cardiomyopathy, Complication, Pregnancy
- What is being tested?
- Extracorporeal Membrane Oxygenation
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2019to 31 Mar 2020
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women treated with ECMO while pregnant or immediately postpartum (within six months).
Who may be able to join
- Female
- Age 18 years or greater at the time of ECMO treatment.
- Pregnant or within 6 months post-partum at the time of ECMO cannulation
Who cannot join
- No history of pregnancy.
- No treatment with ECMO.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
The goal of this study is to describe the use of ECMO (Extracorporeal Membrane Oxygenation) in the pregnant or peripartum patient.
- Being tested
- Extracorporeal Membrane Oxygenation
- Medical subject headings
- Shock, Cardiogenic, Peripartum Cardiomyopathy, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Membrane OxygenationDevice
Use of ECMO for circulatory / hemodynamic support of peripartum of pregnant patients who developed cardiogenic shock.
| Study group | Role | What they receive |
|---|---|---|
| Cardiogenic Shock Treated with ECMO | This cohort of participants required clinical intervention with ECMO for treatment of their index cardiogenic shock episode while pregnant or post delivery of their infant. Receives: Device: Extracorporeal Membrane Oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome of Mother
Describe clinical course of pregnant or recently postpartum patients with cardiogenic shock treated with ECMO, including the rate of neonate survival
Measured: Time of diagnosis -Six Month Survival Rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start28 Oct 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Thordsen
- Sponsor type
- University, hospital or other
- Collaborators
- Medical College of Wisconsin
- Responsible party
- Sponsor-investigator, Sarah Thordsen, Medical College of Wisconsin
- Investigators
- Sarah Thordsen, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144660
- Sponsor's protocol ID
- PRO00036221
- Status last verified
- Nov 2020
- First submitted
- 28 Oct 2019
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- 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 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Treatment Use of ECMO In Pregnancy or Peripartum Patient."
- ClinicalTrials.gov ID
- NCT04144660
- Acronym / sponsor ID
- PRO00036221
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sarah ThordsenUniversity, hospital or other
- Collaborators
- Medical College of Wisconsin
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 30 Oct 2019 (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.
The goal of this study is to describe the use of ECMO (Extracorporeal Membrane Oxygenation) in the pregnant or peripartum patient.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiogenic Shock Treated with ECMO | – | Device: Extracorporeal Membrane OxygenationThis cohort of participants required clinical intervention with ECMO for treatment of their index cardiogenic shock episode while pregnant or post delivery of their infant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women treated with ECMO while pregnant or immediately postpartum (within six months).
Key inclusion criteria (3 listed)
- Female
- Age 18 years or greater at the time of ECMO treatment.
- Pregnant or within 6 months post-partum at the time of ECMO cannulation
Key exclusion criteria (2 listed)
- No history of pregnancy.
- No treatment with ECMO.
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 |
|---|---|---|
| Extracorporeal Membrane OxygenationUse of ECMO for circulatory / hemodynamic support of peripartum of pregnant patients who developed cardiogenic shock. | Device | Cardiogenic Shock Treated with ECMO |
Primary outcome
Clinical Outcome of Mother
Time frame: Time of diagnosis -Six Month Survival Rate
Describe clinical course of pregnant or recently postpartum patients with cardiogenic shock treated with ECMO, including the rate of neonate survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- 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.
Sarah Thordsen, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Peripartum Cardiomyopathy, run by Sarah Thordsen at 1 site in United States.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcome of Mother (time frame: Time of diagnosis -Six Month Survival Rate). 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 23 Nov 2020.