Official Title: “Extending Acute Stroke Trials to the Aerial Inter-Hospital Transfer Setting”

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).

Study Type: Interventional

Study Design: Other, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment

Study Primary Completion Date: January 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Ranitidine
  • 50 mg single dose injection of Ranitidine
• Drug: Placebo
  • 50 mg single dose injection of normal saline (placebo)
• Other: Advanced notification
  • Advanced notification of study via faxed consent to local ER
• Other: No advanced notification
  • No advanced notification of study via faxed consent to local ER

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: I
  • Advanced Notification + Ranitidine
• Active Comparator: II
  • Advanced Notification + Placebo
• Active Comparator: III
  • No advanced notification + Ranitidine
• Placebo Comparator: IV
  • No advanced notification + Placebo

Primary Measures

• Feasibility of conducting research in aerial setting
  • Time Frame: Enrollment
    Safety Issue?: No

Secondary Measures

• Prevention of chemical pneumonitis
  • Time Frame: Day of discharge
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Iowa

Overall Clinical Trial Officials and Contacts

Enrique C Leira, MD Principal Investigator University of Iowa  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00585351

Study ID Number: NIH 5K12RR017700-04

ClinicalTrials.gov Identifier: NCT00585351

Health Authority: United States: Institutional Review Board