The Establishment of a Registry and a Biorepository of Patients With Suspected Amniotic Fluid Embolism (AFE) (AFE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05791786|
Recruitment Status : Recruiting
First Posted : March 30, 2023
Last Update Posted : April 3, 2023
|Condition or disease||Intervention/treatment|
|Amniotic Fluid Embolism||Other: Patient|
The registry and the biorepository have prospective and retrospective components.
The prospective component of the registry and the biorepository focuses on the collection of demographic, clinical, and biological material of patients prospectively identified as having the AFE syndrome, including the collection of future samples from survivors and related individuals. Typically, healthcare providers, family members of an affected patient, or patients themselves contact the AFE Foundation. The AFE Foundation provides information about the natural history of the syndrome and its outcomes and invites patients to participate in the registry and biorepository. The AFE Foundation obtains informed consent from patients or next of kin for enrollment in this observational study. There is no randomization or placebo group for this registry as it is exclusively an observational study. If maternal specimens are available pre- and post-event during the hospital admission for delivery, these samples will also be collected from each patient. The only group assignment will be the subjects with a diagnosis of AFE and the subjects' family members including the partner(s) and child (children).
The retrospective component of the registry consists of obtaining clinical information and biological material from patients who have been previously affected by the AFE syndrome. This objective includes obtaining medical records, patient-provided information, pathology reports, autopsy reports, and tissue blocks. Biological samples can also be obtained from survivors and relatives to determine whether there are biomarkers in previously affected patients or whether biomarkers can be elicited from the stimulation of peripheral blood cells. In addition to collecting data and specimens from the patients that are consented and enrolled through the registry, a query of all maternal deaths within 24 hours of birth between 1/2012 to 1/2023 will be performed at the Hermann Hospital system to identify if any of these deaths occurred secondary to AFE. The investigators intend to perform a detailed chart review and collect otherwise discarded tissue if available from the respective hospital to perform special immunohistochemistry staining among women who underwent autopsy.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||400 participants|
|Target Follow-Up Duration:||2 Weeks|
|Official Title:||The Establishment of a Registry and a Biorepository of Patients With Suspected Amniotic Fluid Embolism (AFE)|
|Actual Study Start Date :||July 5, 2022|
|Estimated Primary Completion Date :||October 1, 2031|
|Estimated Study Completion Date :||December 31, 2031|
participants of the AFE registry and biorepository include affected individuals diagnosed with AFE
All subjects or their next of kin must be able to provide a signed and dated informed consent form.
In the case of lethal AFE, the surviving family member or next of kin must be able to provide a signed and dated informed consent form with an accompanying death certificate and proof of legal kinship
affected individuals diagnosed with AFE
- To establish a clinical registry of suspected cases of AFE [ Time Frame: 1 year ]The existing registry will be migrated to a new platform, thus to enhance and strengthen the content and the quality of the data obtained.
- The existing registry will be migrated to a new platform, thus to enhance and strengthen the content and the quality of the data obtained. [ Time Frame: 2 weeks ]biological materials would be sought from mothers, their children, and other related individuals
- To obtain clinical data and biological specimens from individuals previously enrolled in the registry [ Time Frame: 3 weeks ]This objective includes the review of autopsy material and pathology reports, as well as the collection of biological material of survivors and members of the family, to determine whether there is a susceptibility to the AFE syndrome
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05791786
|Contact: Miranda Klassenfirstname.lastname@example.org|
|Contact: Irene Stafford, MDemail@example.com|
|United States, Texas|
|The University of Texas Health Science Center at Houston||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Sunbola Ashimi, PhD 713-500-6410 firstname.lastname@example.org|
|Principal Investigator:||Irene Stafford, MD||UT Health Science Center Health Science Center|