Extending Acute Stroke Trials to the Aerial Inter-hospital Transfer Setting

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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 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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Iowa
• Treatments: Ranitidine; Ranitidine bismuth citrate

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 recombinant tissue Plasminogen Activator (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.

• 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.