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

NCT ID: NCT00585351

Last Updated: 2013-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-01-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Blinding Strategy: DOUBLE

Study Groups

I

Advanced Notification + Ranitidine

Group Type: EXPERIMENTAL

Ranitidine

Intervention Type: DRUG

50 mg single dose injection of Ranitidine

Advanced notification

Intervention Type: OTHER

Advanced notification of study via faxed consent to local Emergency Room (ER)

II

Advanced Notification + Placebo

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

50 mg single dose injection of normal saline (placebo)

Advanced notification

Intervention Type: OTHER

Advanced notification of study via faxed consent to local Emergency Room (ER)

III

No advanced notification + Ranitidine

Group Type: ACTIVE_COMPARATOR

Ranitidine

Intervention Type: DRUG

50 mg single dose injection of Ranitidine

No advanced notification

Intervention Type: OTHER

No advanced notification of study via faxed consent to local Emergency Room (ER)

IV

No advanced notification + Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

50 mg single dose injection of normal saline (placebo)

No advanced notification

Intervention Type: OTHER

No advanced notification of study via faxed consent to local Emergency Room (ER)

Interventions

Ranitidine

50 mg single dose injection of Ranitidine

Intervention Type: DRUG

Placebo

50 mg single dose injection of normal saline (placebo)

Intervention Type: DRUG

Advanced notification

Advanced notification of study via faxed consent to local Emergency Room (ER)

Intervention Type: OTHER

No advanced notification

No advanced notification of study via faxed consent to local Emergency Room (ER)

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enrique C Leira, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

NIH 5K12RR017700-04

Identifier Type: -

Identifier Source: secondary_id

NIH 5K12RR017700-04

Identifier Type: -

Identifier Source: org_study_id