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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT00585351
First received: December 26, 2007
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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).


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 (AIRDOC)

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • The Benefit of Advanced Notification in Promoting Informed Consent [ Time Frame: Assessed at time of enrollment into the study. ] [ Designated as safety issue: No ]
    Number of subjects that provided informed consent for study (advanced notification vs. no advanced notification).


Secondary Outcome Measures:
  • Prevention of Chemical Pneumonitis [ Time Frame: Assessed on the day of discharge (average length of stay is approximately 3-7 days) ] [ Designated as safety issue: No ]
    Number of subjects that did not develop aspiration pneumonia in the intervention group (Ranitidine vs. placebo).


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 Emergency Room (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 Emergency Room (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 Emergency Room (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 Emergency Room (ER)

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.

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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
Results First Received: August 16, 2011
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Ranitidine
Ranitidine bismuth citrate
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine Agents
Histamine Antagonists
Histamine H2 Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014