StrokeAIRDOCNCT00585351
Extending Acute Stroke Trials to the Aerial Inter-hospital Transfer Setting
A study testing Ranitidine, Advanced notification and No advanced notification in people with Stroke, run by University of Iowa at 1 site in United States.
Trial summary
We are inviting patients who have been diagnosed with an ischemic or hemorrhagic stroke and are being transferred by Air Care helicopters to the University of Iowa Hospitals and Clinics (UIHC) for further care to participate in this research study to test the following: 1) To test whether it is possible to go through… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Ranitidine, Advanced notification and No advanced notification
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jan 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Presumed Ischemic stroke or intracerebral hemorrhage within past 12 hours.
- NIH Stroke Scale (NIHSS) score >/=1 point.
- Negative pregnancy test (females < 50 years old).
- No pre-stroke disability (Rankin Scale Score 0-1).
- Patient evaluated for intravenous recombinant tissue Plasminogen Activator (rtPA) and intubation by the local physicians (if appropriate).
Who cannot join
- Onset of symptoms > 12 hours or uncertain time of origin (if patient awakens with stroke, the time of onset will be the last time patient was normal).
- Reason for the transfer is to receive rtPA at the University of Iowa.
- Non-stroke etiology for symptoms.
- Temperature > 37.8 C.
- Systolic blood pressure < 100 mm Hg.
- Known allergy to ranitidine.
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- White Blood Cell (WBC) > 10K.
- Hemoglobin < 9.0.
- Platelets < 100,000.
- Glucose < 60 or > 300 mg/dl.
- Current need for antibiotics.
- Terminal illness with expected survival < 3 months.
- Prison inmate or institutionalized individual.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extending Acute Stroke Trials to the Aerial Inter-hospital Transfer Setting (AIRDOC)
We are inviting patients who have been diagnosed with an ischemic or hemorrhagic stroke and are being transferred by Air Care helicopters to the University of Iowa Hospitals and Clinics (UIHC) for further care to participate in this research study to test the following: 1) To test whether it is possible to go through all the procedures necessary to start a study, including an informed consent, before the patient is transferred by helicopter to Iowa City. 2)To test a low risk medication called, Ranitidine, that might lower the chances of developing chemical pneumonitis (irritation of the lungs by stomach contents), a fairly common complication in patients that have had a stroke. Patients will be randomly assigned to receive a single dose injection of either Ranitidine (50 milligrams (mg)) or placebo (normal saline).
Read the detailed description
Ischemic or hemorrhagic stroke patients transferred by Air Care helicopters to the University of Iowa Hospitals and Clinics (UIHC) for further care will be invited to participate in a research study testing the following: 1) feasibility of beginning a research study while the patient is in transit to UIHC, and 2)test efficacy of a low risk medication called, Ranitidine, to help lower the chances of developing chemical pneumonitis in patients that have had a stroke.
Patients will be randomly assigned to receive a single dose injection of either Ranitidine (50 mg) or placebo (normal saline). Independently of the study injection, the patient will continue to receive the usual standard medical care for their stroke. The patient will be cared for by a team of doctors in the stroke service. Some of these doctors and nurses are investigators for this study and will assess the patient's neurological status to see how much the stroke has affected the patient. They will also determine by the patient's symptoms and the results of a chest x-ray (if that test becomes necessary due to fever) whether the patient has developed chemical pneumonitis They will also administer a questionnaire to the patient or their relative prior to discharge about their thoughts on doing clinical studies while being transported by the helicopter and to collect any thoughts they may have had about improving this process. Completing the questionnaire is voluntary, and the patient is free to skip any question that they would prefer to not answer.
Three months after the patient has had the stroke, they or their relative will be contacted by phone to determine the patient's long-term outcome after their stroke. After the follow-up telephone conversation the participation in the study will end.
- Conditions
- Stroke
- Being tested
- Ranitidine, Placebo, Advanced notification, No advanced notification
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanitidineDrug
50 mg single dose injection of Ranitidine
PlaceboDrug
50 mg single dose injection of normal saline (placebo)
Advanced notificationOther
Advanced notification of study via faxed consent to local Emergency Room (ER)
No advanced notificationOther
No advanced notification of study via faxed consent to local Emergency Room (ER)
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Advanced Notification + Ranitidine Receives: Drug: Ranitidine; Other: Advanced notification |
| II | Active comparator | Advanced Notification + Placebo Receives: Drug: Placebo; Other: Advanced notification |
| III | Active comparator | No advanced notification + Ranitidine Receives: Drug: Ranitidine; Other: No advanced notification |
| IV | Placebo comparator | No advanced notification + Placebo Receives: Drug: Placebo; Other: No advanced notification |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Benefit of Advanced Notification in Promoting Informed Consent
Number of subjects that provided informed consent for study (advanced notification vs. no advanced notification).
Measured: Assessed at time of enrollment into the study.
Secondary outcomes (1)
Prevention of Chemical Pneumonitis
Number of subjects that did not develop aspiration pneumonia in the intervention group (Ranitidine vs. placebo).
Measured: Assessed on the day of discharge (average length of stay is approximately 3-7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrique C Leira, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585351
- Sponsor's protocol ID
- NIH 5K12RR017700-04
- Other IDs
- NIH 5K12RR017700-04
- Acronym
- AIRDOC
- Status last verified
- Jan 2013
- First submitted
- 26 Dec 2007
- Last updated
- 16 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extending Acute Stroke Trials to the Aerial Inter-hospital Transfer Setting (AIRDOC)
- ClinicalTrials.gov ID
- NCT00585351
- Acronym / sponsor ID
- AIRDOC / NIH 5K12RR017700-04
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 3 Jan 2008 (estimated)
- Results
- Posted 16 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are inviting patients who have been diagnosed with an ischemic or hemorrhagic stroke and are being transferred by Air Care helicopters to the University of Iowa Hospitals and Clinics (UIHC) for further care to participate in this research study to test the following: 1) To test whether it is possible to go through all the procedures necessary to start a study, including an informed consent, before the patient is transferred by helicopter to Iowa City. 2)To test a low risk medication called, Ranitidine, that might lower the chances of developing chemical pneumonitis (irritation of the lungs by stomach contents), a fairly common complication in patients that have had a stroke. Patients will be randomly assigned to receive a single dose injection of either Ranitidine (50 milligrams (mg)) or placebo (normal saline).
Detailed description
Ischemic or hemorrhagic stroke patients transferred by Air Care helicopters to the University of Iowa Hospitals and Clinics (UIHC) for further care will be invited to participate in a research study testing the following: 1) feasibility of beginning a research study while the patient is in transit to UIHC, and 2)test efficacy of a low risk medication called, Ranitidine, to help lower the chances of developing chemical pneumonitis in patients that have had a stroke.
Patients will be randomly assigned to receive a single dose injection of either Ranitidine (50 mg) or placebo (normal saline). Independently of the study injection, the patient will continue to receive the usual standard medical care for their stroke. The patient will be cared for by a team of doctors in the stroke service. Some of these doctors and nurses are investigators for this study and will assess the patient's neurological status to see how much the stroke has affected the patient. They will also determine by the patient's symptoms and the results of a chest x-ray (if that test becomes necessary due to fever) whether the patient has developed chemical pneumonitis They will also administer a questionnaire to the patient or their relative prior to discharge about their thoughts on doing clinical studies while being transported by the helicopter and to collect any thoughts they may have had about improving this process. Completing the questionnaire is voluntary, and the patient is free to skip any question that they would prefer to not answer.
Three months after the patient has had the stroke, they or their relative will be contacted by phone to determine the patient's long-term outcome after their stroke. After the follow-up telephone conversation the participation in the study will end.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: Ranitidine, Other: Advanced notificationAdvanced Notification + Ranitidine |
| II | Active comparator | Drug: Placebo, Other: Advanced notificationAdvanced Notification + Placebo |
| III | Active comparator | Drug: Ranitidine, Other: No advanced notificationNo advanced notification + Ranitidine |
| IV | Placebo comparator | Drug: Placebo, Other: No advanced notificationNo advanced notification + Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Presumed Ischemic stroke or intracerebral hemorrhage within past 12 hours.
- NIH Stroke Scale (NIHSS) score >/=1 point.
- Negative pregnancy test (females < 50 years old).
- No pre-stroke disability (Rankin Scale Score 0-1).
Key exclusion criteria (13 listed)
- Onset of symptoms > 12 hours or uncertain time of origin (if patient awakens with stroke, the time of onset will be the last time patient was normal).
- Reason for the transfer is to receive rtPA at the University of Iowa.
- Non-stroke etiology for symptoms.
- Temperature > 37.8 C.
- Systolic blood pressure < 100 mm Hg.
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 |
|---|---|---|
| Ranitidine50 mg single dose injection of Ranitidine | Drug | I, III |
| Placebo50 mg single dose injection of normal saline (placebo) | Drug | II, IV |
| Advanced notificationAdvanced notification of study via faxed consent to local Emergency Room (ER) | Other | I, II |
| No advanced notificationNo advanced notification of study via faxed consent to local Emergency Room (ER) | Other | III, IV |
Primary outcome
The Benefit of Advanced Notification in Promoting Informed Consent
Time frame: Assessed at time of enrollment into the study.
Number of subjects that provided informed consent for study (advanced notification vs. no advanced notification).
1 secondary outcome
Prevention of Chemical Pneumonitis
Time frame: Assessed on the day of discharge (average length of stay is approximately 3-7 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Enrique C Leira, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ranitidine, Advanced notification and No advanced notification in people with Stroke, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Benefit of Advanced Notification in Promoting Informed Consent (time frame: Assessed at time of enrollment into the study.). 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 16 Jan 2013.