NCT05905900

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2019

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

4 years

First QC Date

June 7, 2023

Last Update Submit

June 7, 2023

Conditions

StrokeDye Allergy

Keywords

StrokeEmergent IV Dye PrepDye Allergy

Outcome Measures

Primary Outcomes (1)

  • Adverse Reactions

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

    24 Hours

Study Arms (1)

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

Interventions

Emergent IV Dye PreparationCOMBINATION_PRODUCT

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

Emergent IV Dye Preparation & Administration

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke alert patients with a history of dye allergies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President and CEO Global Neurosciences Institute

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 15, 2023

Study Start

January 1, 2015

Primary Completion

January 18, 2019

Study Completion

June 1, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

US(1)