StrokeNCT05905900
Emergent Prep for IV Dye in Acute Stroke Patients With Allergy
An observational study of Stroke and Dye Allergy, run by Global Neurosciences Institute at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Dye Allergy
- What is being tested?
- Emergent IV Dye Preparation
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2015to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Stroke alert patients with a history of dye allergies.
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
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emergent Intravenous Dye Preparation for Acute Stroke Patients With a History of Intravenous Dye Allergy
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.
Read the 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.
- Conditions
- Stroke, Dye Allergy
- Being tested
- Emergent IV Dye Preparation
- Keywords
- Stroke, Emergent IV Dye Prep, Dye Allergy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergent IV Dye PreparationCombination product
Diphenhydramine 50 mg IV once, famotidine 20 mg IV once, and dexamethasone 10 mg IV once
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Emergent IV Dye Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Reactions
Unwanted side effects of medication administration, including but not limited to itching, rash, mild shortness of breath etc.
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jan 2015
- Primary completion18 Jan 2019
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global Neurosciences Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Drexel University College of Medicine
- Responsible party
- Principal investigator, Erol Veznedaroglu, Global Neurosciences Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905900
- Sponsor's protocol ID
- IVDyeAllergy
- Status last verified
- Jun 2023
- First submitted
- 7 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergent Intravenous Dye Preparation for Acute Stroke Patients With a History of Intravenous Dye Allergy
- ClinicalTrials.gov ID
- NCT05905900
- Acronym / sponsor ID
- IVDyeAllergy
- Conditions
- Stroke, Dye Allergy
- Keywords
- Stroke, Emergent IV Dye Prep, Dye Allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Global Neurosciences InstituteUniversity, hospital or other
- Collaborators
- Drexel University College of Medicine
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergent IV Dye Preparation & Administration | – | Combination Product: Emergent IV Dye PreparationThe emergent IV dye drug trio is administered and followed immediately by Computed Tomography (CT) Angiography and/or CT Perfusion. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Stroke alert patients with a history of dye allergies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergent IV Dye PreparationDiphenhydramine 50 mg IV once, famotidine 20 mg IV once, and dexamethasone 10 mg IV once | Combination product | Emergent IV Dye Preparation & Administration |
Primary outcome
Adverse Reactions
Time frame: 24 Hours
Unwanted side effects of medication administration, including but not limited to itching, rash, mild shortness of breath etc.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Dye Allergy, run by Global Neurosciences Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Reactions (time frame: 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.