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Plasma

High ACE Activity Fresh Frozen Plasma for Angioedema

Phase 2

Waitlist Available

Led By Steven J Weintraub, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up compare serum ace activity before treatment and at 2 hours and 8 hours after treatment

Awards & highlights

Study Summary

This trial will test a new treatment for a life-threatening side effect of a widely-used class of drugs.

Eligible Conditions

ACE Inhibitor Angioedema

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ compare serum ace activity before treatment and at 2 hours and 8 hours after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~compare serum ace activity before treatment and at 2 hours and 8 hours after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and compare serum ace activity before treatment and at 2 hours and 8 hours after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine if Treatment With 2 Units of Fresh Frozen Plasma That Contains ≥ 50 U/L of ACE Activity Increases Serum ACE Activity

Secondary outcome measures

Determine How Treatment Affects the Severity of Angioedema Using a Published Validated Clinical Rating Scale

Sustained Change in Serum ACE Activity With Treatment

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: High ACE Activity Fresh Frozen PlasmaExperimental Treatment1 Intervention

Subjects will be treated with 2 units of fresh frozen plasma that have been preselected to contain ACE activity ≥50 U/L

Group II: Normal SalinePlacebo Group1 Intervention

Subjects will be treated with normal saline 500 cc.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,707 Total Patients Enrolled

Steven J Weintraub, M.D.Principal InvestigatorWashington University School of Medicine and the St. Louis VA Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the usage of High ACE Activity Fresh Frozen Plasma recognized by the FDA?

"The safety of High ACE Activity Fresh Frozen Plasma has been roughly evaluated as a 2, primarily because this is an exploratory Phase 2 trial that lacks evidence regarding efficacy but does have some background data affirming its security."

Answered by AI

How many participants are currently enrolled in this clinical trial?

"Affirmative. According to clinicaltrials.gov, the trial commenced on December 22nd 2020 and is actively recruiting patients after its most recent edit in October 24th 2022. The study is looking for 30 individuals at one medical site."

Answered by AI

Are there any vacancies available for prospective patients in this experiment?

"According to clinicaltrials.gov, this research study is actively recruiting participants at the time of writing. The trial was initially posted on December 22nd 2020 and has had its details most recently revised on October 24th 2022."

Answered by AI

Recent research and studies

The Journal of Allergy and Clinical Immunology: In PracticeJournal

Possible Donor-dependent Differences in Efficacy of Fresh Frozen Plasma for Treatment of ACE Inhibitor–induced Angioedema

Chen, Sara X., Daniela Hermelin, and Steven J. Weintraub. 2019. “Possible Donor-dependent Differences in Efficacy of Fresh Frozen Plasma for Treatment of ACE Inhibitor–induced Angioedema”. The Journal of Allergy and Clinical Immunology: In Practice. Elsevier BV. doi:10.1016/j.jaip.2019.02.027.

clinicaltrials.govStudy

Treatment of Angiotensin Converting Enzyme Inhibitor-induced Angioedema

2020. "Treatment of Angiotensin Converting Enzyme Inhibitor-induced Angioedema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04679311.