Emergent Prep for IV Dye in Acute Stroke Patients With Allergy

Stroke Clinical Trial

Official title:

Emergent Intravenous Dye Preparation for Acute Stroke Patients With a History of Intravenous Dye Allergy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05905900
• Other study ID #: IVDyeAllergy
• Status: Enrolling by invitation
• Start date: January 1, 2015
• Est. completion date: June 2023

Study information

• Verified date: June 2023
• Source: Global Neurosciences Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: June 2023
• Est. primary completion date: January 18, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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

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Related Conditions & MeSH terms

• Hypersensitivity
• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Global Neurosciences Institute	Drexel University College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Reactions	Unwanted side effects of medication administration, including but not limited to itching, rash, mild shortness of breath etc.	24 Hours