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

NCT00585351 | Completed Results DMC

• 1 other identifier: NIH 5K12RR017700-04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• The Benefit of Advanced Notification in Promoting Informed Consent

  Number of subjects that provided informed consent for study (advanced notification vs. no advanced notification).

  Assessed at time of enrollment into the study.

Secondary Outcomes (1)

• Prevention of Chemical Pneumonitis

  Assessed on the day of discharge (average length of stay is approximately 3-7 days)

Study Arms (4)

I

EXPERIMENTAL

Advanced Notification + Ranitidine

Drug: Ranitidine; Other: Advanced notification

II

ACTIVE COMPARATOR

Advanced Notification + Placebo

Drug: Placebo; Other: Advanced notification

III

ACTIVE COMPARATOR

No advanced notification + Ranitidine

Drug: Ranitidine; Other: No advanced notification

IV

PLACEBO COMPARATOR

No advanced notification + Placebo

Drug: Placebo; Other: No advanced notification

Interventions

Ranitidine DRUG

50 mg single dose injection of Ranitidine

I; III

Placebo DRUG

50 mg single dose injection of normal saline (placebo)

II; IV

Advanced notification OTHER

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

I; II

No advanced notification OTHER

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

III; IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Ranitidine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Some procedural errors by the helicopter crew at the start of the trial, reliability of the stroke diagnosis from the outside hospital, and the possibility for a lower consent rate if a higher risk profile medication were used instead of Ranitidine.

Results Point of Contact

• Title: Enrique Leira, MD, MS
• Organization: University of Iowa

enrique-leira@uiowa.edu

319-356-8755

Study Officials

• Enrique C Leira, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 3, 2008
• Study Start: January 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: January 16, 2013
• Results First Posted: January 16, 2013

Record last verified: 2013-01

Locations

US (1)