Emergent Prep for IV Dye in Acute Stroke Patients With Allergy

Sponsor
Global Neurosciences Institute (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05905900
Collaborator
Drexel University College of Medicine (Other)
50
1
101
0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Emergent IV Dye Preparation

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Emergent Intravenous Dye Preparation for Acute Stroke Patients With a History of Intravenous Dye Allergy
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jan 18, 2019
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Combination Product: Emergent IV Dye Preparation
Diphenhydramine 50 mg IV once, famotidine 20 mg IV once, and dexamethasone 10 mg IV once

Outcome Measures

Primary Outcome Measures

  1. Adverse Reactions [24 Hours]

    Unwanted side effects of medication administration, including but not limited to itching, rash, mild shortness of breath etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All

Inclusion Criteria: Stroke alert patients that required advanced neuroimaging of CTP/CTA and received emergent IV dye preparation -

Exclusion Criteria: patients who reported dye allergies specific to airway edema or anaphylaxis

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Philadelphia Pennsylvania United States

Sponsors and Collaborators

  • Global Neurosciences Institute
  • Drexel University College of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erol Veznedaroglu, President and CEO Global Neurosciences Institute, Global Neurosciences Institute
ClinicalTrials.gov Identifier:
NCT05905900
Other Study ID Numbers:
  • IVDyeAllergy
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Erol Veznedaroglu, President and CEO Global Neurosciences Institute, Global Neurosciences Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2023