Extending Acute Stroke Trials to the Aerial Inter-Hospital Transfer Setting - Full Text View

Sponsor:	University of Iowa
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00585351

Purpose

We are inviting patients who have been diagnosed with an ischemic or hemorrhagic stroke and are being transferred by helicopter 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 mg) or placebo (normal saline).

Condition	Intervention
Stroke	Drug: Ranitidine Drug: Placebo Other: Advanced notification Other: No advanced notification

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator)
Official Title:	Extending Acute Stroke Trials to the Aerial Inter-Hospital Transfer Setting

Resource links provided by NLM:

Drug Information available for: Ranitidine Ranitidine Hydrochloride Ranitidine bismuth citrate

U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:

Feasibility of conducting research in aerial setting [ Time Frame: Enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Prevention of chemical pneumonitis [ Time Frame: Day of discharge ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	January 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: I Advanced Notification + Ranitidine	Drug: Ranitidine 50 mg single dose injection of Ranitidine Other: Advanced notification Advanced notification of study via faxed consent to local ER
Active Comparator: II Advanced Notification + Placebo	Drug: Placebo 50 mg single dose injection of normal saline (placebo) Other: Advanced notification Advanced notification of study via faxed consent to local ER
Active Comparator: III No advanced notification + Ranitidine	Drug: Ranitidine 50 mg single dose injection of Ranitidine Other: No advanced notification No advanced notification of study via faxed consent to local ER
Placebo Comparator: IV No advanced notification + Placebo	Drug: Placebo 50 mg single dose injection of normal saline (placebo) Other: No advanced notification No advanced notification of study via faxed consent to local ER

Detailed Description:

Ischemic or hemorrhagic stroke patients transferred by helicopter 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 rtPA and intubation by the local physicians (if appropriate).

Exclusion Criteria:

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.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585351

Locations

United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

University of Iowa

Investigators

Principal Investigator:

Enrique C Leira, MD

University of Iowa

More Information

No publications provided

Responsible Party:	Enrique Leira, MD, University of Iowa
ClinicalTrials.gov Identifier:	NCT00585351 History of Changes
Other Study ID Numbers:	NIH 5K12RR017700-04, NIH 5K12RR017700-04
Study First Received:	December 26, 2007
Last Updated:	February 20, 2008
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Ranitidine

Ranitidine bismuth citrate
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012