The Establishment of a Registry and a Biorepository of Patients With Suspected Amniotic Fluid Embolism (AFE) (AFE)
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| ClinicalTrials.gov Identifier: NCT05791786 |
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Recruitment Status :
Recruiting
First Posted : March 30, 2023
Last Update Posted : April 3, 2023
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| Tracking Information | |||||||||
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| First Submitted Date | March 17, 2023 | ||||||||
| First Posted Date | March 30, 2023 | ||||||||
| Last Update Posted Date | April 3, 2023 | ||||||||
| Actual Study Start Date | July 5, 2022 | ||||||||
| Estimated Primary Completion Date | October 1, 2031 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | The Establishment of a Registry and a Biorepository of Patients With Suspected Amniotic Fluid Embolism (AFE) | ||||||||
| Official Title | The Establishment of a Registry and a Biorepository of Patients With Suspected Amniotic Fluid Embolism (AFE) | ||||||||
| Brief Summary | To establish a clinical registry of suspected cases of AFE. The existing registry will be migrated to a new platform, | ||||||||
| Detailed Description | 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. |
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| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 2 Weeks | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Maternal blood, umbilical cord blood, and neonatal samples:
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Pregnant and postpartum women, survivors, offspring, and relatives of patients with suspected AFE through enrollment or chart review. | ||||||||
| Condition | Amniotic Fluid Embolism | ||||||||
| Intervention | Other: Patient
affected individuals diagnosed with AFE
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| Study Groups/Cohorts | AFE
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 Intervention: Other: Patient
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
400 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2031 | ||||||||
| Estimated Primary Completion Date | October 1, 2031 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria for participants of the AFE registry and biorepository include affected individuals diagnosed with AFE (see below).
The classification of AFE is for research purposes only. Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT05791786 | ||||||||
| Other Study ID Numbers | HSC-MS-21-1004 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | Irene Stafford, The University of Texas Health Science Center, Houston | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | The University of Texas Health Science Center, Houston | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Amniotic Fluid Embolism (AFE) Foundation | ||||||||
| Investigators |
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| PRS Account | The University of Texas Health Science Center, Houston | ||||||||
| Verification Date | March 2023 | ||||||||