Clinical trial NCT00585351
Conditions: Stroke
Sponsor: University of Iowa
Start date: 2007-01-01; Completion date: 2008-01-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief 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).

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.

Arms: arm 1: Advanced Notification + Ranitidine arm 2: Advanced Notification + Placebo arm 3: No advanced notification + Ranitidine arm 4: No advanced notification + Placebo
Interventions: intervention 1: Ranitidine intervention 2: Placebo intervention 3: Advanced notification intervention 4: No advanced notification
Intervention descriptions: intervention 1: 50 mg single dose injection of Ranitidine intervention 2: 50 mg single dose injection of normal saline (placebo) intervention 3: Advanced notification of study via faxed consent to local Emergency Room (ER) intervention 4: No advanced notification of study via faxed consent to local Emergency Room (ER)

Protocol documents: