Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05905900
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-06-15
First Post:
2023-06-07
Brief Title:
Emergent Prep for IV Dye in Acute Stroke Patients With Allergy
Sponsor:
Global Neurosciences Institute
Organization:
Global Neurosciences Institute
Study Overview
Official Title:
Emergent Intravenous Dye Preparation for Acute Stroke Patients With a History of Intravenous Dye Allergy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor CT Perfusion
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 studys inclusion criteria consisted of all stroke alert patients from 2021-2022 who required advanced neuroimaging of CTPCTA 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 patients 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
To evaluate the relationship between dye allergy and any adverse reactions our studys inclusion criteria consisted of all stroke alert patients from 2021-2022 who required advanced neuroimaging of CTPCTA 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None