Emergent Prep for IV Dye in Acute Stroke Patients With Allergy

NCT ID: NCT05905900

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Our institution implemented a protocol to administer an emergent IV dye preparation for stroke alert patients requiring advanced neuroimaging. The emergent IV dye preparation consists of diphenhydramine 50 mg IV once, famotidine 20 mg IV once, and dexamethasone 10 mg IV once, followed immediately by Computed Tomography (CT) Angiography and/or CT Perfusion.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients with documented IV dye allergy were given emergent dye preparation immediately prior to advanced neuroimaging that consisted of three drugs: diphenydramine 50 mg IV, famotidine 20 mg IV, and dexamethasone 10 mg IV. In contrast, elective dye preparation commonly done in non-emergent or outpatient settings is separated into two different options. The first option is for a patient to take Prednisone 50 mg three times prior to the study: one tablet by mouth 13 hours prior, one tablet by mouth seven hours prior, and the last tablet by mouth one hour prior to the study. The second option is for the patient to be prescribed dexamethasone 4 mg or 6 mg dispensed four times: two tablets by mouth 12 hours prior to the study and 2 tablets by mouth one hour prior to the study. If the patient is prescribed dexamethasone, they also take famotidine 150 mg and diphenhydramine 50 mg, both drugs by mouth 12 hours prior and one hour prior to the study.

To evaluate the relationship between dye allergy and any adverse reactions, our study's inclusion criteria consisted of all stroke alert patients from 2021-2022 who required advanced neuroimaging of CTP/CTA and received emergent IV dye preparation. Exclusion criteria included patients who reported dye allergies specific to airway edema or anaphylaxis. A retrospective chart review was done to evaluate stroke patient's stated allergies, the number of patients that received emergent IV dye preparation, and any adverse reactions despite the emergent IV dye preparation. Data was then analyzed to determine if there was a relationship between prior contrast dye allergy and allergic reactions that occurred after emergent IV dye administration.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Dye Allergy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Emergent IV Dye Preparation & Administration

The emergent IV dye drug trio is administered and followed immediately by Computed Tomography (CT) Angiography and/or CT Perfusion.

Emergent IV Dye Preparation

Intervention Type COMBINATION_PRODUCT

Diphenhydramine 50 mg IV once, famotidine 20 mg IV once, and dexamethasone 10 mg IV once

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Emergent IV Dye Preparation

Diphenhydramine 50 mg IV once, famotidine 20 mg IV once, and dexamethasone 10 mg IV once

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Drexel University College of Medicine

OTHER

Sponsor Role collaborator

Global Neurosciences Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Erol Veznedaroglu

President and CEO Global Neurosciences Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IVDyeAllergy

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cord Blood Infusion for Ischemic Stroke
NCT02397018 COMPLETED PHASE1
ReoPro and Retavase to Treat Acute Stroke
NCT00046293 COMPLETED PHASE2
Dapsone for Acute Ischemia Stroke Study
NCT01144650 UNKNOWN PHASE2/PHASE3